BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1994188 · Received February 16, 2011

    Report

    Report Number
    2024168-2011-00940
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE MONOFILAMENT WAS EXPOSED APPROXIMATELY 2 INCHES AT THE GUIDE WITH THE POSTERIOR CUFF AND NEEDLE TIP STILL ATTACHED TO THE RAIL END. BOTH CUFFS WERE STILL ATTACHED TO THE LINK. THE ANTERIOR CUFF WAS OUT OF THE POCKET AND THE TABS WERE BENT PROPERLY AND UNDISTURBED. THERE WAS NO NEEDLE STRIKE MARK ON THE FOOT. BASED ON THE EVIDENCE FOUND ON THE RETURNED DEVICE, THE ANTERIOR CUFF WAS MISSED AND THIS MAY APPEAR LIKE A SUTURE BREAK BECAUSE THERE WAS NO SUTURE AT THE END OF THE PLUNGER. DURING THE INVESTIGATION, THE 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 ANTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE DURING NEEDLE DEPLOYMENT. 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

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHILE ADVANCING THE KNOT THE SUTURE BROKE. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED 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 940186H

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention