BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOOK

    MDR report key: 791660 · Received December 1, 2006

    Report

    Report Number
    2522801-2006-00001
    Event Type
    Other
    Date Received
    December 1, 2006
    Date of Event
    October 3, 2006
    Report Date
    November 30, 2006
    Manufacturer
    ANGIOTECH(FORMERLY SURGICAL SPECIALITES)
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR DID NOT HAVE ANY OF THE "USED" SUTURE TO RETURN BUT DID RETURN ONE (1) UNUSED STERILE SAMPLE FROM THE SAME LOT FOR EVALUATION ON 11/07/2006. THE PIECE WAS TESTED ON 11/21/2006. A VISUAL INSPECTION OF PACKAGING MATERIAL, SEAL INTEGRITY, STRIP AND BURST TESTING, VISUAL INSPECTION OF SUTURE, DIAMETER AND TENSILE TEST WERE PERFORMED ON THE ONE (1) SAMPLE PIECE RETURNED TO ANGIOTECH (FORMERLY SURGICAL SPECIALTIES) BY THE DOCTOR'S OFFICE. ALL RESULTS WERE ACCEPTABLE AND MET THE CURRENT U.S.P. AND ANGIOTECH (FORMERLY SURGICAL SPECIALTIES) SPECIFICATION REQUIREMENTS. THE IFU FOR THIS ITEM STATES "USERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING ABSORBABLE SURTURES BEFORE EMPLOYING PGA SUTURES FOR WOUND CLOSURE, AS RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE OF APPLICATION AND THE SUTURE MATERIAL USED. ADEQUATE KNOT SECURITY FOR SYNTHETIC ABSORBABLE SUTURES, WHICH ARE COATED TO ENHANCE HANDLING CHARACTERISTICS, REQUIRES THE ACCEPTABLE SURGICAL TECHNIQUE OF FLAT, SQUARE TIES, WITH ADDITIONAL THROWS AS WARRANTED BY SURGICAL CIRCUMSTANCE AND THE EXPERIENCE OF THE SURGEON." THE DOCTOR DID NOT PROVIDE INFORMATION ON KNOT TECHNIQUE OR THE TYPE OF STITCH USED TO APPROXIMATE THE INCISION. THE IFU ALSO STATES "THE USE OF THIS SUTURE MAY BE INAPPROPRIATE IN ELDERLY, MALNOURISHED, DEBILITATED PATIENTS OR PATIENTS SUFFERING FROM CONDITIONS WHICH MAY DELAY WOUND HEALING."

    Description of Event or Problem · 1

    DOCTOR'S (DERMATOLOGIST) ASSISTANT REPORTED ON 10/27/2006 THE DOCTOR'S CONCERN REGARDING THE PERFORMANCE OF 4/0 ABSORBABLE PGA SUTURE (ITEM#386B-LOT#M833340) MANUFACTURED BY ANGIOTECH (FORMERLY SURGICAL SPECIALTIES) HOWEVER SPECIFIC INFORMATION WASN'T OBTAINED UNTIL 11/20/2006 WHEN WE COULD CONVERSE WITH THE DOCTOR BY CONFERENCE CALL. SHE INFORMED US THAT THIS PARTICULAR BOX OF SUTURE WAS LOSING TENSILE STRENGTH, ABSORBING TOO QUICKLY COMPARED TO OTHER 4/0 PGA SUTURE SHE HAS USED IN THE PAST. WITHIN A MONTH TIME, FIVE (5) ELDERLY PATIENTS HAD INCISIONS DEHISCE A WEEK OR TWO FOLLOWING THE REMOVAL OF SURFACE SUTURES. THE 4/0 PGA SUTURE WAS USED TO CLOSE THE SUBCUTANOUS TISSUE LAYER AND NYLON SUTURE WAS USED TO CLOSE THE SURFACE INCISION. THE PATIENTS RETURNED TO THE DOCTOR TO HAVE THE INCISIONS RE-STITCHED. THE DOCTOR USED THE SAME TYPE OF PGA PRODUCT TO RE-STITCH WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOK SUTURE AND NEEDLE GAM ANGIOTECH(FORMERLY SURGICAL SPECIALITES) 386B M833340

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention