BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2110687 · Received June 1, 2011

    Report

    Report Number
    2024168-2011-03818
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 FOUR ADDITIONAL PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. A CUFF MISS (NO SUTURE RETRIEVED/ATTACHED) CAN OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT BECAUSE OF 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. THIS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THIS EVENT, BUT COULD NOT BE CONFIRMED. THE RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, IN PROCESS TESTING OF DEVICES IS PERFORMED TO ASSURE THERE IS NO NEEDLE DEFLECTION, WHICH MAY CAUSE THE EVENT REPORTED IN THIS CASE. A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC MANUFACTURING OR PRODUCT DEFICIENCY.

    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, A SUTURE MISS WAS EXPERIENCED. AN ATTEMPT WAS MADE WITH FOUR ADDITIONAL PROGLIDE DEVICES UNSUCCESSFULLY. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 860196H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention