BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1487182 · Received September 28, 2009

    Report

    Report Number
    2953144-2009-01311
    Event Type
    Injury
    Date Received
    September 28, 2009
    Date of Event
    September 8, 2009
    Report Date
    September 8, 2009
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. DEVICE #1 STARCLOSE SE, PART# 12337-05, LOT# 75035-6H, IS BEING FILED UNDER MEDWATCH MFR #: 2953144-2009-01310.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: SUTURE BREAK. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL USING THE PERCLOSE PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS RETRACTED TO HARVEST THE SUTURE, THE SUTURE BROKE. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED PATIENT ADVERSE EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 75035-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LOT# 75035-6H| DEVICE #1 PERCLOSE A-T, PART# 12337-05,