BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K032008

    MDR report key: 857654 · Received May 31, 2007

    Report

    Report Number
    6000126-2007-00059
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    April 27, 2007
    Report Date
    May 8, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJT
    PMA / PMN Number
    K032008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT REPORTED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS THE DEVICE WAS DISCARDED AT THE FACILITY. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. A DEVICE HISTORY RECORD REVIEW AS PERFORMED. ALL RECORDS APPEARED NORMAL AND NO RELATED QUALITY ISSUES OR MANUFACTURING DEFICIENCIES WERE NOTED AT THE TIME OF MANUFACTURE. THERE HAVE BEEN NO PREVIOUS COMPLAINTS REPORTED AGAINST LOT NUMBER 1173646. THERE HAVE BEEN NO PREVIOUS COMPLAINTS REPORTED AGAINST LOT 1173646. THE COMPLIANT IS INCONCLUSIVE AS THE CUSTOMER DID NOT RETURN A PRODUCT SAMPLE. WITHOUT RECEIVING A PRODUCT SAMPLE FOR EVALUATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. A REVIEW OF THE APRIL 2007 COMPLAINT REPORT FOR THE VAXCEL PASV PORT PRODUCT FAMILY NOTED NO ADVERSE TRENDS TO THE REPORTED DEFECT OF "SHEATH TEAR ISSUES," SHEATH INSERTION DIFFICULTY," SHEATH BROKE," OR "WINGS BROKE OFF P-A SHEATH."

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT DURING THE THERAPEUTIC IMPLANT OF THE DEVICE IN A PT (AGE AND GENDER UNK), THE PEEL-A-WAY SHEATH BEGAN TO APPROPRIATELY PEEL ALONG THE PERFORATION FOR APPROX ONE THIRD OF THE WAY DOWN. THE SHEATH THEN BROKE OFF AT THE WING. THE PHYSICIAN WAS ABLE TO COMPLETE THE PEELING OF THE SHEATH WITH THE AID OF A SURGICAL TOOL, AND BY CUTTING DOWN AND RETRIEVING THE REMAINING PORTION OF THE SHEATH AND PULLING DOWN THE REMAINING PORTION. THE COMPLAINANT REPORTED THAT THE PHYSICIAN SUCCESSFULLY COMPLETED THIS PT PROCEDURE WITH THIS DEVICE. THE COMPLAINANT REPORTED THAT THERE WERE NO ADVERSE AFFECTS TO THE PT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K032008 LJT BOSTON SCIENTIFIC NA 1173646

    Patients

    Seq Age Sex Outcome Treatment
    1 YR