BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2802132 · Received October 23, 2012

    Report

    Report Number
    2024168-2012-06703
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT 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 BREAKAGE WAS NOT CONFIRMED DUE TO THE SUTURE NOT BEING RETURNED AND SUCCESSFUL TESTING OF THE RETURNED GATED SUTURE TRIMMER USING A PROXY SUTURE. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER IT MOST LIKELY RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. 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 INDICATED 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 AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PHYSICIAN WAS AT THE SINGLE-HANDED POSITION TO COMPLETE KNOT ADVANCEMENT USING THE SUTURE TRIMMER, THE RAIL SUTURE (BLUE SUTURE) SUDDENLY TORE OFF. THE REMAINED SUTURE WAS REMOVED OUTSIDE THE BODY AND MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. IT WAS INDICATED THAT IT IS POSSIBLE THAT THE PHYSICIAN APPLIED MORE TENSION THAN REQUIRED CAUSING THE RAIL SUTURE TO TEAR OFF. THE PHYSICIAN IS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. 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 20725J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6 FR HEPARIN