Mallinckrodt Hemostat SolutionsMallinckrodt Hemostat Solutions

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Indications

PREVELEAK® Surgical sealant is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Supplied in a convenient, prefilled syringe1,2

No thawing or mixing required1

Minimal preparation1,2

Simple steps to preparing PREVELEAK for use1

PREVELEAK Preparation Step 5: Remove the cap
  1. Remove from box and allow PREVELEAK to reach room temperature prior to use.
  2. Open the outer pouch and place the inner sterile pouch onto the sterile field.
  3. Open the inner pouch and remove the double-barrel syringe and delivery tips.
  4. Hold the syringe by the barrel, cap end upward.
  5. Remove the cap by turning 90° counterclockwise and pulling upwards, using a slight side-to-side rocking motion. Note how the cap attaches and detaches, since the delivery tip is attached in the same manner. (See photo.)
PREVELEAK Preparation Step 6a: Attach the delivery tip to the syringe
  1. Attach the delivery tip to the syringe as follows: Locate the small alignment tab on the hub end of the delivery tip. Locate the corresponding V-shaped alignment notch in one of the two upper locking wings at the open end of the syringe. Align the tab in the notch, and push delivery tip into place. (See photo 6a.)
PREVELEAK Preparation Step 6b: Lock the tip to the syringe

Turn delivery tip 90° clockwise to lock the tip to the syringe.

(See photo 6b.)

Designed for simple, precise application1

Applying PREVELEAK

  1. Ensure that the application site is clamped and there is no active bleeding.
  2. Prime the syringe by discarding the first 0.25 mL of sealant immediately prior to use.
  3. Apply the sealant in a slow and steady manner over the top of the suture line with the delivery tip approximating the sutures.
  4. After the application is complete, leave the clamps in place for at least 60 seconds before restoring circulation, applying irrigation, blotting with gauze, or touching sealant.
  5. Prior to restoring circulation, carefully use blunt dissection to ease away any sealant attached to the clamps. Gently remove clamps without disturbing the sealant at the application site.
  6. Do not manipulate the synthetic graft or patch.

If necessary, PREVELEAK can be easily removed from instruments and tissue without causing damage.3

PREVELEAK applied to suture line PREVELEAK applied to synthetic vascular graft
Golden tint allows for precise placement and removal if needed.

Indications

PREVELEAK® Surgical sealant is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Important Risk Information

Contraindications

  • Not for use in patients with known allergies to materials of bovine or shellfish origin.
  • Not for intravascular use.
  • Not for cerebrovascular repair or cerebrospinal leak repair.

Warnings and Precautions

  • Do not use as a substitute for sutures or staples.
  • Avoid exposure to nerves.
  • Do not use in the presence of obvious infection and use with caution in contaminated areas of the body.
  • Do not allow either the uncured or polymerized form to contact circulating blood.
  • PREVELEAK contains a material of animal origin that may be capable of transmitting infectious agents.
  • Repeated use of PREVELEAK in subsequent surgeries has not been studied.
  • Hypersensitivity reactions were not seen using PREVELEAK, but hypersensitivity of BSA has been reported.
  • Avoid contact with skin or other tissue not intended for application.
  • Safety and effectiveness of PREVELEAK in minimally invasive procedures or coronary artery bypass grafting (CABG) have not been established.
  • Do not use blood saving devices when suctioning excess PREVELEAK from the surgical field.
  • PREVELEAK syringe and delivery tips are for single patient use only. Do not resterilize.
  • Do not use if packages have been opened or damaged.
  • Take care not to spill contents of syringe. Avoid tissue contact with material expelled from delivery tip during priming.
  • Avoid pausing more than 10-15 seconds between priming and application to prevent polymerization within the delivery tip.
  • Minimize use in patients with abnormal calcium metabolism (e.g. chronic renal failure, hyperparathyroidism). Polyaldehyde treated tissue can have an enhanced propensity for mineralization.
  • Evidence of cytotoxicity was observed during cell culture-based laboratory assays and is believed to be due to the polyaldehyde component of the product. No evidence of cytotoxicity was observed in animal or clinical studies.

Adverse Reactions

  • Potential adverse effects associated with the use of this class of surgical sealants include application of the sealant to tissue not targeted for the procedure, failure of the sealant to adhere to the tissue, hypersensitivity reaction such as swelling or edema at the application site, possible transmission of infectious agents from materials of animal origin, thrombosis and thromboembolism.
  • Serious adverse events that occurred in clinical studies included death, hypotension, thrombosis/thromboembolism, ischemia, respiratory failure/dysfunction, steal syndrome, and myocardial infarction.

Use In Specific Populations

  • Use of PREVELEAK in pediatric or pregnant patients has not been studied.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the complete Instructions for Use here.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898.

References: 1. PREVELEAK Surgical sealant [instructions for use]. Hazelwood, MO: Mallinckrodt Hospital Products Inc; 2016. 2. Tenaxis Medical, Inc. Summary of safety and effectiveness: ArterX Surgical Sealant. March 1, 2013. 3. Tenaxis Medical, Inc. Clinical evaluation report for ArterX Surgical Sealant. April 22, 2013.