BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2032932 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02131
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 (NO SUTURE RETRIEVED/ATTACHED) 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 A CUFF-MISS. A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. THE REPORTED USE OF THE PROGLIDE DEVICE IN A CALCIFIED ARTERY IS INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU). THE IFU, UNDER SPECIAL PATIENT POPULATION STATES THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. IT SHOULD BE NOTED THAT THE PATIENTS HISTORY OF PERIPHERAL VASCULAR DISEASE MAY HAVE ALSO PLAYED A ROLE IN THE REPORTED EXPERIENCE. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE CANNOT 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 A MODERATELY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS PULLED BACK NO SUTURES WERE ATTACHED TO THE NEEDLES. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 85 YR Required Intervention