BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1934909 · Received December 21, 2010

    Report

    Report Number
    2953144-2010-03310
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE INDICATED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES DURING NEEDLE DEPLOYMENT; HOWEVER, THE LINK BROKE AT THE POSTERIOR CUFF DURING SUTURE RETRIEVAL. A LINK BREAK WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING PLUNGER RETRACTION AND CAN APPEAR VERY SIMILAR TO THE REPORTED NEEDLE-TO-CUFF MISS. DURING LAB TESTING, THE PLUNGER WAS REINSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY RESISTANCE THAT COULD CONTRIBUTE TO A LINK BREAK AT THE POSTERIOR CUFF. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE LINK BREAK COULD NOT BE DETERMINED BASED ON OUR INVESTIGATION. 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE #1 AND #3 PROGLIDE PART #12673-03, LOT #920516H, ARE BEING FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    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 AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, THERE WAS NO SUTURE PRESENT. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND AND THIRD PROGLIDE DEVICE WAS ATTEMPTED, BUT ALSO RESULTED IN A NEEDLE-TO-CUFF MISS. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 920516H

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention HEPARIN, DEVICE #2 AND #3 PROGLIDE (LOT#: 920516H)