BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3222808 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04334
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. REPORTEDLY, DURING DEVICE PREPARATION THE MARKER LUMEN TUBE APPEARED TO BE BENT. THE PERCLOSE PROGLIDE DEVICE INSTRUCTIONS FOR USE (IFU) STATES UNDER THE PRECAUTIONS SECTION TO INSPECT THE PERCLOSE PROGLIDE SMC SYSTEM PRIOR TO USE TO ENSURE THAT THE STERILE PACKAGING HAS NOT BEEN DAMAGED DURING SHIPMENT. EXAMINE ALL COMPONENTS PRIOR TO USE TO VERIFY PROPER FUNCTION. EXERCISE CARE DURING DEVICE HANDLING TO REDUCE THE POSSIBILITY OF ACCIDENTAL DEVICE BREAKAGE. ADDITIONALLY, ALTHOUGH MARKER LUMEN PATENCY COULD NOT BE VERIFIED DURING PREPARATION, THE DEVICE WAS INSERTED AND ADVANCED INTO THE COMMON FEMORAL ARTERY. THE IFU STATES UNDER THE EXAMINATION AND SELECTION OF PRODUCTS SECTION TO VERIFY MARKER LUMEN PATENCY BY FLUSHING THE MARKER LUMEN WITH SALINE UNTIL THE SALINE EXITS THE MARKER PORT. DO NOT USE THE PERCLOSE PROGLIDE SMC DEVICE IF THE MARKER LUMEN IS NOT PATENT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED BENT AND NON-PATENCY OF THE MARKER LUMEN TUBE WAS CONFIRMED. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING 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. PER THE PERCLOSE PROGLIDE DEVICE INSTRUCTIONS FOR USE (IFU) THE OPERATOR IS INSTRUCTED TO INSPECT THE PERCLOSE PROGLIDE SMC SYSTEM PRIOR TO USE TO EXAMINE ALL COMPONENTS PRIOR TO USE TO VERIFY PROPER FUNCTION. EXERCISE CARE DURING DEVICE HANDLING TO REDUCE THE POSSIBILITY OF ACCIDENTAL DEVICE BREAKAGE. ADDITIONALLY, ALTHOUGH MARKER LUMEN PATENCY COULD NOT BE VERIFIED DURING PREPARATION, THE DEVICE WAS INSERTED AND ADVANCED INTO THE COMMON FEMORAL ARTERY. THE IFU STATES TO VERIFY MARKER LUMEN PATENCY BY FLUSHING THE MARKER LUMEN WITH SALINE UNTIL THE SALINE EXITS THE MARKER PORT. DO NOT USE THE PERCLOSE PROGLIDE SMC DEVICE IF THE MARKER LUMEN IS NOT PATENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC CORONARY ANGIOGRAM, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, DURING DEVICE PREPARATION THE MARKER LUMEN TUBE APPEARED TO BE BENT, THE MARKER LUMEN WAS FLUSHED WITH SALINE, BUT THE SALINE DID NOT EXIT THE MARKER PORT. ALTHOUGH MARKER LUMEN PATENCY COULD NOT BE VERIFIED DURING PREPARATION, THE DEVICE WAS INSERTED AND ADVANCED INTO THE COMMON FEMORAL ARTERY, BUT NO BLOOD FLOW WAS EVIDENT FROM THE MARKER LUMEN. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322374 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30405K1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SHEATH: 5-FRENCH