BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3222881 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04337
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SUTURE RETRIEVAL ISSUE WAS CONFIRMED. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL PROCEDURE, ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, WHEN THE SUTURES WERE HARVESTED FROM THE DEVICE, THE WHITE SUTURE WAS NOT PRESENT, ONLY THE BLUE SUTURE. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323069 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30409K1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SHEATH: 6-FRENCH| HEPARIN