BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1932113 · Received December 17, 2010

    Report

    Report Number
    2953144-2010-03269
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 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): 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE FOOT WAS PROPERLY PARKED INSIDE THE GUIDE BRIDGE. THERE WAS NO TISSUE FOUND ATTACHED TO THE ANTERIOR FOOT. DURING THE INVESTIGATION OF THE DEVICE, THE LEVER WAS ACTIVATED SEVERAL TIMES AND THE FOOT DEPLOYED AND PARKED WITHOUT A PROBLEM. THERE WAS NO ABNORMAL OBSERVATION FOUND ON THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THERE WAS NO SIGN OF FOOT SURFING. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE WAS DEPLOYED SUCCESSFULLY AND PERFORMED ACCORDING TO SPECIFICATIONS; THEREFORE THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD 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 PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE LEVER WAS LOWERED TO PARK THE FOOT, AND WHEN THE DEVICE WAS BEING WITHDRAWN RESISTANCE WAS FELT. THE PHYSICIAN OBSERVED THAT TISSUE WAS CONNECTED TO THE ANTERIOR FOOT OF THE DEVICE AND THAT THE FOOT WAS ONLY PARTIALLY CLOSED. MANUAL COMPRESSION WAS HELD ON THE RIGHT GROIN TO CONTROL THE BLEEDING. ACCESS WAS GAINED ON THE LEFT GROIN, A RIGHT FEMORAL ANGIOGRAM REVEALED A DISSECTION/FLAP AT THE RIGHT COMMON FEMORAL ARTERY, WHERE THE DEVICE WAS INSERTED. TWO NON-ABBOTT SELF EXPANDING STENTS WERE USED ACROSS THE FLAP AND THE BLEEDING STOPPED. MANUAL COMPRESSION WAS APPLIED ON THE LEFT GROIN TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT SEQUELAE. 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 940346H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention HEPARIN