BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1022121 · Received March 25, 2008

    Report

    Report Number
    2953144-2008-00198
    Event Type
    Malfunction
    Date Received
    March 25, 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 SUMMARY: EVAL OF THE RETURNED DEVICE FOUND A POSTERIOR FOOT BREAK. THE PLUNGER, SUTURE, LINK CUFFS AND NEEDLE WERE NOT RETURNED WITH THE DEVICE. WE WERE UNABLE TO DETERMINE THE ROOT CAUSE BASED ON THE INVESTIGATION FINDINGS. NO MANUFACTURING ISSUES WERE 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: HEMOSTASIS ACHIEVED BY UNK METHOD. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE 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 POSTERIOR FOOT BREAK 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