BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2850813 · Received November 29, 2012

    Report

    Report Number
    2024168-2012-07529
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    July 31, 2012
    Report Date
    November 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULT TO POSITION KNOT COULD NOT BE CONFIRMED AS THE SUTURE WAS NOT RETURNED FOR EVALUATION AND THE CONDITION OF THE RETURNED DEVICE DID NOT INDICATE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY THAT WOULD CONTRIBUTE TO THE REPORTED EXPERIENCE. 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL CORONARY PROCEDURE, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF A NON-CALCIFIED AND NON-TORTUOUS COMMON FEMORAL ARTERY USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, THE DEVICE WAS INSERTED INTO THE VESSEL OVER A GUIDE WIRE AND POSITIONED ACHIEVING ARTERIAL MARKING WITH PULSATILE BLOOD FLOW FROM THE MARKER LUMEN OF THE DEVICE. THE GUIDE WIRE WAS REMOVED THROUGH THE GUIDE WIRE EXIT PORT. AFTER SUTURE DEPLOYMENT, THE DEVICE WAS WITHDRAWN UNTIL THE GUIDE WIRE PORT EXITS THE SKIN LINE. THE SUTURE WAS GRASPED ADJACENT TO THE SHEATH AND THE ENDS OF THE SUTURE WERE PULLED THROUGH THE DISTAL END OF THE PROXIMAL GUIDE. ALTHOUGH THE SUTURE WAS COMPLETELY REMOVED FROM THE DEVICE AND THE DEVICE WAS REMOVED FROM THE PATIENT, THE BLUE RAIL SUTURE WITH THE KNOT WAS TIGHTENED AND WAS UNABLE TO BE MOVED. THE SUTURE WAS REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE FINAL OUTCOME OF THE PATIENT WAS REPORTED TO BE SATISFACTORY. 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20511J1

    Patients

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