BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1914220 · Received December 3, 2010

    Report

    Report Number
    2953144-2010-03091
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE#1:PROGLIDE(PART#12673-03,LOT# 940016H) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE NEEDLE PLUNGER, LINK, ANTERIOR NEEDLE, AND ANTERIOR CUFF, WERE NOT RETURNED WITH THE DEVICE, WHICH LIMITED THE SCOPE OF THE INVESTIGATION. INSPECTION OF THE RETURNED DEVICE REVEALED A LINK BREAK OCCURRED AT THE POSTERIOR CUFF DURING NEEDLE PLUNGER RETRACTION. SUBSEQUENTLY, THE SUTURE COULD NOT BE RETRIEVED AS REPORTED. DURING TESTING, THE PROXY PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY RESISTANCE THAT COULD CONTRIBUTE TO A LINK BREAK AT THE POSTERIOR CUFF. THE WHOLE SUTURE COULD BE PULLED FROM THE NEEDLE SLOT WITHOUT ANY OBSERVABLE RESISTANCE THAT COULD RESULT IN A LINK BREAK DURING NEEDLE PLUNGER RETRACTION. BASED ON THE INVESTIGATION, THE ROOT CAUSE FOR THE LINK BREAK AT THE POSTERIOR CUFF COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING WAS OBSERVED ON THE EGM, INDICATIVE OF A DAMAGED LEAD.

    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 THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, THERE WAS NO SUTURE PRESENT ON THE NEEDLES. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE WAS ATTEMPTED BUT ALSO RESULTED IN A NEEDLE-TO-CUFF MISS. A THIRD PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 AV-REDWOOD CITY 940016H

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention DEVICE#1:PROGLIDE(PART#12673-03,LOT# 940016H)