BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1934884 · Received December 21, 2010

    Report

    Report Number
    2953144-2010-03330
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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.PERCLOSE PROGLIDES (PART #12673-03, LOT #940206H) INDICATED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE FOOT WAS PROPERLY PARKED INSIDE THE GUIDE BRIDGE. DURING THE INVESTIGATION, THE LEVER WAS ACTIVATED AND THE FOOT DEPLOYED AND PARKED WITHOUT ANY PROBLEM. THERE WAS NO ABNORMAL OBSERVATION WITH THE CONDITION OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE WAS DEPLOYED SUCCESSFULLY; THEREFORE, A ROOT CAUSE FOR THE REPORTED FOOT PLATE NOT CLOSING COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. 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 A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE FOOT PLATE WOULD NOT CLOSE. TWO ADDITIONAL PROGLIDES WERE USED WITH THE SAME RESULTS. THE METHOD HOW HEMOSTASIS WAS ACHIEVED WAS NOT REPORT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. 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 930196H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PERCLOSE PROGLIDE(X2): PART 12673-03, LOT 940206H