BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1902346 · Received November 11, 2010

    Report

    Report Number
    2953144-2010-02832
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS - (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE SECOND PERCLOSE PROGLIDE (PART 12673-03, LOT 900336H), INDICATED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC ANGIOGRAPHY. REPORTEDLY, A CUFF MISS OCCURRED AND A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. ANOTHER PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. A FEMORAL ANGIOGRAM WAS NOT TAKEN BEFORE DEVICE PLACEMENT. THE PT WAS REPORTED TO BE FAIRLY OBESE. THERE WAS NO ADVERSE PT EFFECT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 - VASCULAR SOLUTIONS NA 900336H

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention (PART 12673-03, LOT 900336H)| VESSEL CLOSURE: #2 PERCLOSE PROGLIDE