BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3930377 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04477
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE REPORTED FAILURE TO CLOSE THE VESSEL COULD NOT BE CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD AND A QUERY OF COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. 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 WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 7F SHEATH AFTER AN INTERVENTIONAL PROCEDURE FOR PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (PAOD). REPORTEDLY, AFTER THE SUTURE WAS DEPLOYED AND THE KNOT WAS ADVANCED TO THE ARTERY, HEMOSTASIS WAS NOT ACHIEVED BECAUSE PATIENT'S BLOOD PRESSURE (BP) WAS REPORTED TO BE 180. THE PATIENT'S BP WAS CONTROLLED TO 110 BY A NTG DRUG (NITROGLYCERIN). HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406760 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31021K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7FR, HEPARIN