BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2823094 · Received November 7, 2012

    Report

    Report Number
    2024168-2012-07024
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INVESTIGATION. 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 EVENT WAS CONFIRMED. BASED ON THE VISUAL INSPECTION AND FUNCTIONAL ANALYSIS 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUFF MISS OCCURRED DURING ATTEMPTED SUTURE PLACEMENT IN A COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. THE ARTERIOTOMY WAS 6F AND THE VESSEL WAS MILDLY TORTUOUS. A SECOND PROGLIDE DEVICE WAS USED FOR SUCCESSFUL SUTURE PLACEMENT. THE TAVI PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED WITH THE SECOND PROGLIDE DEVICE SUTURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT WAS REPORTED THAT THE PHYSICIAN IS 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20806J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 18FHEPARIN