BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDICATED CLOSURE (SMC) SYSTEM

    MDR report key: 1364504 · Received April 16, 2009

    Report

    Report Number
    2953144-2009-00430
    Event Type
    Injury
    Date Received
    April 16, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 23, 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. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFORMATION. DEVICE #1 PERCLOSE A-T, PART# 12337-06, LOT# 69032-6H, IS BEING FIELD UNDER MEDWATCH MANUFACTURER REPORT NUMBER: 2935144-2009-00429.

    Description of Event or Problem · 1

    DEVICE#2 MALFUNCTION: NEEDLE-TO-CUFF MISS. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF PERCLOSE A-T DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL, AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE DEVICE WAS REMOVED, THE SUTURE PULLED OUT OF THE VESSEL. A SECOND PERCLOSE A-T WAS ATTEMPTED, BUT WHEN THE NEEDLE PLUNGER WAS RETRACTED, A NEEDLE TIP DID NOT CAPTURE A CUFF. THE DEVICE WAS REMOVED AND AN ANGIO-SEAL WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDICATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 69032-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #1 PERCLOSE A-T: PART# 12337-06| LOT# 69032-6H