BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2152081 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04796
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT REPORTED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT THE DEVICE EVALUATION, A CAUSE FOR THE SUTURES NOT ACHIEVING A TIGHT SEAL COULD NOT BE DETERMINED. FAILURE TO ACHIEVE HEMOSTASIS MAY BE DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, USER TECHNIQUE, OPERATIONAL CONTEXT, ANATOMICAL CONDITIONS, OR MANUFACTURING. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. THE INFORMATION PROVIDED IS LIMITED AND A PROBABLE CAUSE CANNOT BE DETERMINED FOR THE EXPERIENCED EVENT. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN AND THE DEVICE WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE AND THE INSPECTION CRITERIA, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE KNOT WAS ADVANCED, THE SUTURES DID NOT HAVE A TIGHT SEAL. OOZING OCCURRED AND PULSATILE BLOOD WAS NOTED. MANUAL ARTERIAL COMPRESSION WAS APPLIED FOR 25 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTEDLY PROFICIENT IN THE USE OF THE DEVICE. THOUGH REQUESTED, THE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention