BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE CLOSURE (SMC) SYSTEM

    MDR report key: 1436742 · Received August 11, 2009

    Report

    Report Number
    2953144-2009-01042
    Event Type
    Injury
    Date Received
    August 11, 2009
    Date of Event
    July 8, 2009
    Report Date
    July 22, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFORMATION. DEVICE #2 PERCLOSE A-T, PART# 12337-06, LOT# 73059-6H, IS BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE #1 MALFUNCTION: UNKNOWN. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE A-T DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE VESSEL WITHOUT COMPLETELY PARKING THE FOOT, WHICH ENLARGED THE ACCESS SITE. THE ARTERIOTOMY SITE DID NOT CLOSE COMPLETELY. THE SUTURE WAS REMOVED AND A SECOND PERCLOSE A-T WAS ATTEMPTED, BUT HEMOSTASIS COULD NOT BE ACHIEVED. MANUAL COMPRESSION WAS APPLIED FOR 1.5 HOURS TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 73059-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #2 PERCLOSE A-T| LOT# 73059-6H