BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2781613 · Received October 10, 2012

    Report

    Report Number
    2024168-2012-06416
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 15, 2012
    Report Date
    September 18, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF A CUFF MISS WAS CONFIRMED. BASED ON VISUAL 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.

    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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION INDICATES THE ARTERIOTOMY WAS A 6F. THE SHEATH WAS UPSIZED TO A 12F AND THEN 18F. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED USING THE PROGLIDE DEVICE IN THE FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED NO SUTURE WAS PRESENT. A SECOND PROGLIDE DEVICE WAS USED FOR SUCCESSFUL SUTURE PLACEMENT AND THE INTERVENTIONAL PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE SUTURE FROM THE SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 20627J1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SHEATH: 6FR, 12FR, 18FR| HEPARIN