BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1251331 · Received December 3, 2008

    Report

    Report Number
    2953144-2008-01934
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 2, 2008
    Report Date
    November 12, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO. DEVICE #1 PROGLIDE, PART# 12673-03, LOT # 68166-6H, IS BEING FILED UNDER MEDWATCH MFR REPORT NUMBER: 2953144-2008-01931. DEVICE #2 PROGLIDE, PART # 12673-03, LOT # 68166-6H, IS BEING FILED UNDER MEDWATCH MFR REPORT NUMBER: 2953144-2008-01932. DEVICE # PROGLIDE, PART# 12673-03, LOT # 68166-6H, IS BEING FILED UNDER MEDWATCH MFR REPORT NUMBER: 2953144-2008-01933.

    Description of Event or Problem · 1

    DEVICE #4 MALFUNCTION: 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 THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT AND RIGHT COMMON FEMORAL ARTERIES AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING ARTERIOTOMY CLOSURE ON THE LEFT COMMON FEMORAL ARTERY, WHEN THE PLUNGER WAS REMOVED, A NEEDLE TIP DID NOT CAPTURE A CUFF. A NEEDLE TO CUFF MISS OCCURRED. A SECOND PERCLOSE PROGLIDE DEVICE WAS ATTEMPTED BUT ANOTHER NEEDLE TO CUFF MISS OCCURRED. A THIRD PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. DURING ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY, A CUFF MISS OCCURRED USING TWO PROGLIDE DEVICES AND REQUIRED A THIRD PROGLIDE TO ACHIEVE HEMOSTASIS. NO ADVERSE PT EFFECTS WERE REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    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 69037-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #2 PROGLIDE: PART# 12673-03| DEVICE #1 PROGLIDE: PART# 12673-03| DEVICE #3 PROGLIDE: PART# 12673-03