BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1902116 · Received November 10, 2010

    Report

    Report Number
    2953144-2010-02814
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    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
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. THE FIRST PERCLOSE PROGLIDE DEVICE (PART 12673-03, LOT 930196H), INDICATED IS BEING FILED UNDER MFR REPORT NUMBER 2953144-2010-02813. THE THIRD PERCLOSE PROGLIDE DEVICE (PART 12673-03, LOT 930196H), INDICATED IS BEING FILED UNDER A SEPARATE MFR REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE PLUNGER, CUFFS, LINK, NEEDLE TIP AND MONOFILAMENT WERE NOT RETURNED. THERE WAS NO NEEDLE STRIKE MARK ON THE FOOT. NO ABNORMAL OBSERVATION WAS FOUND ON THE RETURNED DEVICE. WE WERE UNABLE TO DETERMINE THE CAUSE OR CONFIRM THE REPORTED EVENT BASED ON THE CONDITION OF THE RETURNED DEVICE, DUE TO THE MISSING PARTS. DURING THE INVESTIGATION, A PROXY PLUNGER WAS REINSERTED TO TEST THE NEEDLE TRAJECTORY AND THE RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO PATIENT ANATOMY OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE DURING NEEDLE DEPLOYMENT. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT PRESENTED TO THE HOSPITAL WITH A RUPTURED ANEURYSM AND WAS TREATED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. DURING THE PRE-PROCEDURE ANGIOGRAM, THE IMAGES SHOWED THE RUPTURED ANEURYSM AND AN EXTRAVASATION INTO THE ABDOMEN. THE PROCEDURE ENDED WITH NO REPORTED COMPLICATIONS. THE FINAL ANGIOGRAM IMAGES NO LONGER REVEALED THE EXTRAVASATION AND NO ENDOLEAKS WERE NOTED. THE PT WAS TRANSFERRED TO THE ICU FOR RECOVERY. WHILE IN THE ICU, THE PT BEGAN TO CODE AND GO INTO CARDIAC ARREST. LATER THAT DAY, THE PT EXPIRED. THE CAUSE OF DEATH IS UNK. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ASSESSMENT TO PERFORM A VALVULOPLASTY PROCEDURE, A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE, ATTEMPTED A PRE-CLOSE TECHNIQUE IN THE COMMON FEMORAL ARTERY. REPORTEDLY, THE DEVICE WOULD NOT "PICK UP THE SUTURE" AND A CUFF MISS OCCURRED. A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. ANOTHER PROGLIDE WAS SUCCESSFULLY USED. AFTER ARTERIOTOMY CLOSURE, THE PT EXPERIENCED A HEMATOMA SMALLER THAN 6 CM AND MANUAL COMPRESSION WAS SUCCESSFULLY APPLIED FOR APPROX 15-20 MINUTES. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR-REDWOOD CITY NA 930196H

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention GUIDE WIRE: J WIRE| VESSEL CLOSURE: PERCLOSE PROGLIDE #1| (PART 12673-03, LOT 930196H)| PERCLOSE PROGLIDE #3| (PART 12673-03, LOT 930196H)| DILATATION CATHETER: UNSPECIFIED