BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1973238 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00538
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    November 15, 2010
    Report Date
    January 5, 2011
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. AGAINST RESISTANCE, INCORRECT ANATOMY. THE REPORTED ACTION OF ADVANCING OF THE DEVICE INTO THE VESSEL WITH MUCH FORCE IS NOT CONSISTENT WITH THE DEVICE INSTRUCTION FOR USE (IFU)/DEVICE PLACEMENT SECTION READS: DO NOT ADVANCE OR WITHDRAW THE PERCLOSE PROGLIDE SMC DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE DEVICE SHOULD BE AVOIDED, AS THIS MAY LEAD TO SIGNIFICANT VESSEL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE INTERVENTION AND/OR SURGICAL REMOVAL OF THE DEVICE AND VESSEL REPAIR. PER THE INVESTIGATION DETAILS, THE DEVICE WAS USED OFF LABEL IN A VESSEL- PATCH- PLASTIC WITH SCARRED TISSUE. ADDITIONALLY, THE PATIENT REPORTEDLY SUFFERED FROM PVD WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, BUT CANNOT BE CONFIRMED. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY, AFTER AN INTERVENTIONAL PROCEDURE. A 'VESSEL-PATCH-PLASTIC' WAS LOCATED ON THE PUNCTION SITE, IN THE COMMON FEMORAL ARTERY, WHERE THE CLOSURE DEVICE WAS USED. REPORTEDLY, WHILE ADVANCING THE DEVICE INTO THE VESSEL THROUGH THE PATCH, MUCH FORCE WAS NECESSARY AND THE DEVICE BROKE BETWEEN THE PROXIMAL AND THE DISTAL GUIDE. THE DISTAL GUIDE WAS REMOVED SURGICALLY AND IT WAS INDICATED BY THE REPORTER THAT THE PROCEDURE WENT SMOOTHLY, WITHOUT PROBLEMS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention