BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2981375 · Received February 27, 2013

    Report

    Report Number
    2024168-2013-01152
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SUTURE AND KNOT COMING OUT OF THE VESSEL WHEN THE NEEDLE PLUNGER WAS REMOVED WAS CONFIRMED. BASED ON VISUAL INSPECTION 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 INDICATED DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT WAS REPORTED THAT A FEMORAL ANGIOGRAM WAS NOT PERFORMED. IT SHOULD BE NOTED THAT THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATES TO PERFORM A FEMORAL ANGIOGRAM THROUGH THE INTRODUCER SHEATH TO VERIFY THAT THE ACCESS SITE IS IN THE COMMON FEMORAL ARTERY. TO AVOID POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGATION OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY, FLUOROSCOPICALLY EVALUATE THE FEMORAL ARTERY FOR SIZE, CALCIUM, TORTUOSITY, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) A FEMORAL ANGIOGRAM WAS REPORTEDLY NOT PERFORMED. IT SHOULD BE NOTED THAT THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATES TO PERFORM A FEMORAL ANGIOGRAM THROUGH THE INTRODUCER SHEATH TO VERIFY THAT THE ACCESS SITE IS IN THE COMMON FEMORAL ARTERY. TO AVOID POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGATION OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY, FLUOROSCOPICALLY EVALUATE THE FEMORAL ARTERY FOR SIZE, CALCIUM, TORTUOSITY, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. A FEMORAL ANGIOGRAM WAS NOT PERFORMED PRIOR TO ARTERIOTOMY CLOSURE. ARTERIAL MARKING WAS ACHIEVED AS INDICATED BY A CONTINUOUS DROP OF BLOOD BEING PRESENT FROM THE MARKER LUMEN OF THE DEVICE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED TO CUT THE SUTURES, ALL OF THE SUTURES WITH THE KNOT CAME OUT (OF THE VESSEL). MANUAL ARTERIAL COMPRESSION WAS APPLIED 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
    85055 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20806J1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SHEATH: 6-FRENCH HEPARIN