BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2781578 · Received October 10, 2012

    Report

    Report Number
    2024168-2012-06417
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 17, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. 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; HOWEVER, THE PLUNGER/NEEDLES ASSEMBLY, POSTERIOR NEEDLE TIP, BOTH CUFFS AND LINK WERE NOT RETURNED. THE RETURNED SUTURE WAS FULLY FREE OF THE DEVICE HANDLE AND UNDAMAGED WITH THE KNOT FORMED AND THE TAIL ENDS CLEAN CUT. THE FORMED KNOT AND CLEAN CUT SUTURE END INDICATED PROPER SUTURE DEPLOYMENT AND DELIVERY. THERE WAS NO DETECTED DEVICE HANDLE DAMAGE OR ANOMALY TO SUGGEST A CUFF MISS OCCURRED. BASED ON THE DEVICE CONDITION THE REPORTED CUFF MISS WAS NOT CONFIRMED. HOWEVER THE CONDITION OF THE SUTURE INDICATED THAT THE SUTURE HAD BEEN PULLED FROM THE ANATOMY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS RETRACTED A CUFF MISS HAD OCCURRED. THE VESSEL WAS RE-WIRED AND THE PROGLIDE DEVICE WAS REMOVED. HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20824J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention