BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2034013 · Received March 30, 2011

    Report

    Report Number
    2024168-2011-02165
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. A CUFF MISS CAN OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO 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. ULTIMATELY, THE RETURN OF PROGLIDE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED CUFF MISS. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A 100% IN PROCESS TESTING OF DEVICES ARE 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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS REPORTED EVENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED.

    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 UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE WAS USED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention