BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3840501 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03446
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    March 10, 2014
    Report Date
    May 6, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE RETURNED CONDITION CONFIRMED THE REPORTED CUFF MISS DURING THE PLUNGER RETRACTION ISSUE. BASED ON ANALYSIS OF THE RETURNED DEVICE, NO QUALITY DEFICIENCY WAS DETECTED. A SEARCH OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCES ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ITS INVESTIGATION FINDINGS. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LOT DID NOT REVEAL ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INVESTIGATION, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319458 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31126K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention