BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1971198 · Received January 26, 2011

    Report

    Report Number
    2024168-2011-00480
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    October 26, 2010
    Report Date
    January 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND ONLY THE PLUNGER/NEEDLE ASSEMBLY WAS RETURNED WITH THE ANTERIOR NEEDLE ENGAGED WITH THE ANTERIOR CUFF, THE LINK AND THE POSTERIOR CUFF ATTACHED. MISSING FROM THE DEVICE WAS THE COMPLETE PROGLIDE DEVICE BODY, POSTERIOR NEEDLE TIP AND SUTURE. WITHOUT THE COMPONENTS, IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED LOT NUMBER AND THE SCOPE OF THIS INVESTIGATION WAS LIMITED. THERE WAS NO DETECTED DAMAGE TO THE PLUNGER/NEEDLE ASSEMBLY, ANTERIOR NEEDLE TO ANTERIOR CUFF ENGAGEMENT, OR LINK. INSPECTION OF THE POSTERIOR CUFF DID NOT DETECT ANY DAMAGE AND THE 3 CUFF TABS WERE UNDISTURBED, INDICATING THAT THE POSTERIOR NEEDLE TIP HAD NOT ENGAGED THE CUFF. REMOVAL OF THE PLUNGER/NEEDLE ASSEMBLY FROM THE DEVICE WITHOUT THE SUTURE ATTACHED MAY APPEAR AS A SUTURE BREAK. FOR NEEDLE TO CUFF MISS, POSSIBLE CAUSES ARE NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE, AGGRESSIVE AND FAST DEPLOYMENT OF THE PLUNGER, OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE POSTERIOR CUFF MISS COULD NOT BE DETERMINED. 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. 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 COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS PULLED BACK THE SUTURE BROKE. A NON-ABBOTT 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 900306H

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention