BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-5 SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1269785 · Received December 18, 2008

    Report

    Report Number
    2953144-2008-02074
    Event Type
    Injury
    Date Received
    December 18, 2008
    Date of Event
    July 11, 2008
    Report Date
    December 2, 2008
    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. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. DEVICE#1 - PERCLOSE AT (PART#12337-06; LOT# 68001-6H), IS BEING FILED UNDER MEDWATCH REPORT# 2953144-2008-02073.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: CUFF MISS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE OT ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF PERCLOSE AT DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. THE DEVICE WAS INSERTED INTO THE PATIENT ANATOMY AND THE PLUNGER WAS DEPRESSED PER THE INSTRUCTIONS FOR USE. BEFORE THE LEVER WAS RETURNED TO THE ORIGINAL POSITION TO PARK THE FOOT, THE DEVICE WAS REMOVED FROM THE PATIENT. DURING USE OF A SECOND PERCLOSE AT, IT WAS NOTED THAT A FOOT BREAK OF THE FIRST DEVICE HAD OCCURRED. A CUFF MISS OCCURRED WITH THE SECOND DEVICE. THE FOOT AND "ALL MATERIALS" WERE SURGICALLY RETRIEVED FROM THE PATIENT. HEMOSTASIS WAS ACHIEVED SURGICALLY. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-5 SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 68001-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LOT #68001-6H)| DEVICE #1 - PERCLOSE AT (PART #12337-06,