BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2183035 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05368
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT IT WAS FULLY DEPLOYED WITH BOTH CUFFS CAPTURING THE NEEDLES AND THE RAIL SUTURE END ATTACHED TO THE PLUNGER ASSEMBLY WAS CUT WITH THE DEVICE CUTTER. DURING TESTING, NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL WERE SUCCESSFUL. THE FOOT WAS DEPLOYED AND RETRACTED WITHOUT DIFFICULTY. BASED ON THE INVESTIGATION, THE RETURNED DEVICE WAS FULLY FUNCTIONAL AS INTENDED. AS THE ENTIRE SUTURE WITH THE KNOT WAS NOT RETURNED, IT COULD NOT BE DETERMINED IF THE KNOT WAS SUCCESSFULLY ADVANCED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. THE REPORTED RESISTANCE ENCOUNTERED DURING FOOT DEPLOYMENT AND THE DEVICE DID NOT FEEL LIKE IT WAS FLUSH AGAINST THE ARTERY COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THIS EVENT AND ITS INVESTIGATIONAL FINDINGS. A REVIEW OF THE COMPLAINT-HANDLING DATABASE FOR THIS LOT DID NOT REVEAL ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHILE PULLING THE PLUNGER FROM THE DEVICE BODY, THE SUTURE BROKE. ANOTHER PROGLIDE WAS USED, BUT WHILE LIFTING THE HANDLE TO DEPLOY THE FOOT, RESISTANCE WAS MET. THE LEVER WAS COMPLETELY LIFTED AND THE FOOT WAS DEPLOYED, BUT THE PHYSICIAN DID NOT FEEL LIKE THE DEVICE WAS FLUSH AGAINST THE ANTERIOR WALL OF THE ARTERY. THE FOOT WAS CLOSED AND THE DEVICE WAS REMOVED. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN STATED HE SHOULDERED THE BLAME FOR THE "MISFIRE" AND DID NOT BLAME THE DEVICE PERFORMANCE. REPORTEDLY, THE PHYSICIAN IS TRAINED IN THE USE OF THE DEVICE. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 050186H

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention SHEATH: 6F