BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1936045 · Received December 22, 2010

    Report

    Report Number
    2953144-2010-03340
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER, CUFFS, LINK, NEEDLE TIP AND MONOFILAMENT WERE NOT RETURNED. IT WAS REPORTED THAT THE KNOT WAS FORMED OUTSIDE THE BODY. THE PROBABLE CAUSE FOR THIS CONDITION IS THE DEVICE WAS DEPLOYED OUTSIDE THE ARTERY AND THE KNOT LOCKED WHEN THE NON-RAIL END OF THE MONOFILAMENT WAS PULLED INADVERTENTLY. SINCE THE MONOFILAMENT WAS NOT RETURNED, WHICH IS AN INTEGRAL PART OF THIS INVESTIGATION, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OR CONFIRM THE COMPLAINT. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING SUTURE HARVESTING, THE KNOT WAS FORMED 2-3 INCHES OUTSIDE THE PATIENT'S ANATOMY AND,THEREFORE, COULD NOT BE ADVANCED. THE SUTURES WERE REMOVED AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 AV-REDWOOD CITY 940016H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention