BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1971130 · Received January 26, 2011

    Report

    Report Number
    2024168-2011-00475
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION 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. THERE WAS NO ABNORMAL OBSERVATION FOUND ON THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DUE TO THE MISSING PARTS, THE CAUSE OF THE CONDITION OF THE DEVICE COULD NOT BE DETERMINED OR CONFIRMED. DURING THE INVESTIGATION, A PROXY PLUNGER WAS REINSERTED TO TEST THE NEEDLE TRAJECTORY AND THE RESULT WAS 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 ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORDS 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    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 RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AN ANTERIOR CUFF MISS OCCURRED AS THERE WAS NO SUTURE ATTACHED TO THE NEEDLE WHEN THE PLUNGER WAS REMOVED. ANOTHER PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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-TEMECULA-CT 950146H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention