BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1012472 · Received March 12, 2008

    Report

    Report Number
    2953144-2008-00132
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Report Date
    January 25, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PLUNGER, LINK, AND BOTH CUFFS WERE NOT RETURNED. THERE WERE NO WITNESS MARKS ON THE ANTERIOR FOOT POCKET. THE POSTERIOR FOOT WAS BROKEN. THE ROOT CAUSE FOR THE POSTERIOR FOOT BREAK IS UNDETERMINED. THERE WAS NO MFG ISSUE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FOOT BREAK. TIME OF MALFUNCTION: UNK. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED COMMON FEMORAL ARTERIOTOMY CLOSURE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. DURING DEVICE EVAL ON 2/22/08, A POSTERIOR FOOT BREAK WAS FOUND. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR NA 57003-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK