BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2834169 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07214
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE SECOND PERCLOSE PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS INITIALLY REPORTED TO BE RETURNING; HOWEVER, THE DEVICE WAS NOT RETURNED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED 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 LEFT COMMON FEMORAL ARTERY (LCFA) WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN ENDOVASCULAR ANEURYSM REPAIR. THE LCFA ANTERIOR WALL WAS NOT CALCIFIED. REPORTEDLY, A POSTERIOR CUFF MISS OCCURRED, THE DEVICE WAS REMOVED FROM THE PATIENT OVER THE WIRE. AFTER PROGLIDE REMOVAL AND WHILE THE WIRE WAS IN PLACE THE SCRUB ASSISTANT COMPRESSED THE ARTERY AND A HEMATOMA RESULTED. A SECOND PROGLIDE WAS ATTEMPTED TO BE DEPLOYED IN THE LCFA BUT AN ANTERIOR CUFF MISS OCCURRED. THE SECOND PROGLIDE WAS REMOVED OVER THE WIRE AND AN 8 FR SHEATH WAS PLACED. AT THAT POINT IT WAS DETERMINED TO ACHIEVE HEMOSTASIS PLACING A 10 FR SHEATH. THE 8 FR SHEATH WAS REMOVED. IT WAS INDICATED THAT WHEN THE 10 FR SHEATH WAS PLACED THE HEMATOMA WORSENED. THE 10 FR SHEATH WAS LEFT IN THE GROIN FOR APPROXIMATELY 2 HOURS, FOLLOWED BY MANUAL ARTERIAL COMPRESSION WITH GOOD RESULTS. THE HEMATOMA STABILIZED AND PEDAL PULSES WERE PRESENT. THE HEMATOMA AT TIME OF DISCHARGE FROM THE PROCEDURE ROOM WAS 6-8CM, WITH BRUISING. THE PHYSICIAN IS IN-TRAINING AND CORRECTLY DEPLOYED BOTH PROGLIDE DEVICES UNDER SUPERVISION AND GUIDANCE OF THE ABBOTT CLINICAL SPECIALIST; WHO NOTED THE PHYSICIAN'S TECHNIQUE WAS GOOD. 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 20905J1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SHEATH: 5F, 8F, 10F HEPARIN