BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2833925 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07195
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON VISUAL 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    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. FAILURE TO FOLLOW STEPS. A FEMORAL ANGIOGRAM WAS NOT TAKEN AND IT WAS REPORTED THAT THE DEVICE WAS USED IN A 14F ARTERIOTOMY. THE PERCLOSE PROGLIDE 6F SMC IS DESIGNED FOR USE IN 5F TO 8F ACCESS SITES. IT WAS REPORTED THAT A VENOUS SHEATH WAS NEXT TO THE ARTERIAL SHEATH. THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH IPSILATERAL FEMORAL VENOUS SHEATH DURING THE CATHETERIZATION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT USING A PERCLOSE PROGLIDE DEVICE WAS SUCCESSFUL IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A BALLOON VALVULOPLASTY INTERVENTIONAL PROCEDURE. THE ARTERIOTOMY WAS 6F AND THE VESSEL WAS MODERATELY TORTUOUS. REPORTEDLY, RESISTANCE WAS FELT WHILE RETRACTING THE DEVICE AFTER RETURNING THE LEVER TO ITS ORIGINAL POSITION. FORCE WAS USED TO REMOVE THE DEVICE. IT WAS OBSERVED THAT THE FOOT HAD NOT FULLY RETRACTED IN TO THE PARK POSITION ALTHOUGH THE LEVER WAS IN THE CORRECT POSITION. A SECOND PERCLOSE PROGLIDE DEVICE WAS SUCCESSFULLY DEPLOYED. THE SHEATH SIZE WAS UPSIZED TO 14F FOR THE PROCEDURE. AFTER THE PROCEDURE HEMOSTASIS WAS NOT ACHIEVED USING THE SUTURES OF TWO PERCLOSE PROGLIDE DEVICES. MANUAL ARTERIAL COMPRESSION AND A NON- ABBOTT DEVICE WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS IN-TRAINING IN THE USE OF THE PERCLOSE 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 20915J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 14F HEPARIN