BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1022120 · Received March 25, 2008

    Report

    Report Number
    2953144-2008-00204
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 31, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE RETURNED DEVICE FOUND THAT A POSTERIOR CUFF MISS OCCURRED DUE TO THE FACT THAT THE POSTERIOR CUFF REMAINED IN POCKET. A POSTERIOR CUFF MISS DIRECTLY RESULTED IN A LINK DETACHMENT FROM ANTERIOR CUFF. NO MANUFACTURING ISSUES WERE DETECTED AND WE WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE POSTERIOR CUFF MISS BASED ON INVESTIGATION FINDINGS. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: CUFF MISS. TIME OF MALFUNCTION: UNK. SYMPTOMS/AE: HEMOSTASIS ACHIEVED BY UNK METHOD. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE WAS RETURNED STATING "DEVICE FAILED". DETAILED CASE DESCRIPTION IS UNK BY THE SITE REPORTER. HEMOSTASIS WAS ACHIEVED BY UNK METHOD. DURING DEVICE EVAL IN 2008, A CUFF MISS WAS FOUND. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 REDWOOD CITY NA 59145-6H

    Patients

    Seq Age Sex Outcome Treatment
    1