BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1051056 · Received May 22, 2008

    Report

    Report Number
    2953144-2008-00940
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 28, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #3 CUFF MISS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER A RENAL ARTERY STENTING PROCEDURE. REPORTEDLY, THE PROGLIDE DEVICE FAILED TO DEPLOY, "AS SOON AS THE NEEDLES CAME DOWN THE POSTERIOR FOOT BROKE". A SECOND PROGLIDE DEVICE WAS ATTEMPTED WITH THE SAME RESULTS. A THIRD PROGLIDE DEVICE WAS USED; HOWEVER, A CUFF MISS WAS EXPERIENCED. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. IT IS UNKNOWN IF THE FEET FOR BOTH PROGLIDE DEVICES WERE IN THE PATIENT'S TISSUE TRACT OR OUT OF THE PATIENT'S ANATOMY. THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL FOR OBSERVATION AND WAS DISCHARGED THE FOLLOWING DAY WITHOUT ANY SIGN OF OCCLUSION OR ANY ADDITIONAL INTERVENTION PERFORMED. THERE WERE NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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 63089-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention DEVICE #2 PERCLOSE PROGLIDE 12673-03, LOT#63089-6H| DEVICE #1 PERCLOSE PROGLIDE 12673-03, LOT#63089-6H