BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1920425 · Received December 10, 2010

    Report

    Report Number
    2953144-2010-03198
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE PLUNGER, NEEDLE ASSEMBLY, THE ANTERIOR AND POSTERIOR CUFFS, LINK, POSTERIOR NEEDLE TIP AND SUTURE WERE NOT RETURNED. THE POSTERIOR PORTION OF THE FOOT WAS BROKEN OFF THE FOOT ASSEMBLY AND ALSO NOT RETURNED. WITHOUT THE RETURN OF THE MISSING PARTS, IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED EVENT OF A CUFF MISS. PATIENT ANATOMICAL CONDITIONS SUCH AS OBESITY AND CALCIFICATION CAN INTERFERE WITH NEEDLE DEPLOYMENT, CAUSING THE NEEDLE TO DEFLECT AND STRIKE THE FOOT, BREAKING IT. ADDITIONALLY, CALCIFICATION OR OTHER BODY MATERIAL TRAPPED UNDER THE FOOT DURING DEPLOYMENT CAN INTERFERE AND MAY BREAK THE FOOT. OPERATIONALLY, A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING DEPLOYMENT CAN PUT PRESSURE ON THE FOOT CAUSING IT TO BREAK. BASED ON THE INVESTIGATION FINDINGS, A POSSIBLE ROOT CAUSE FOR THE DEVICES DAMAGED CONDITION IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE #2: PART #12673-03, LOT #930296H IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS PULLED BACK NO SUTURE WAS ATTACHED, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH 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 SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 930296H

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention PROGLIDE, PART #12673-03, LOT #930296HHEPARIN