BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2931402 · Received January 28, 2013

    Report

    Report Number
    2024168-2013-00419
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED CUFF MISS EVENT WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE VESSEL WAS REPORTED TO BE MODERATELY CALCIFIED. THE PROGLIDE INSTRUCTIONS FOR USE (IFU), UNDER SPECIAL PATIENT POPULATION SECTION STATE: THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FLUOROSCOPICALLY VISIBLE VESSEL CALCIUM. THE CALCIFICATION, BEING HARD, HAS THE POTENTIAL TO DEFLECT THE NEEDLE DURING DEPLOYMENT AND RESULT IN THE REPORTED CUFF MISS. THE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE MOST LIKELY RELATED TO THE OPERATIONAL CONTEXT AT TIME OF DEVICE USE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER TWO PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED IN A MODERATELY CALCIFIED COMMON FEMORAL ARTERY WITH PROGLIDE DEVICES USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR. REPORTEDLY, THE VESSEL CALCIFICATION WAS AN ISSUE AND 3 PROGLIDES WERE ATTEMPTED AND ALL RESULTED IN A CUFF MISS. HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37130 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21024J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN