BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 6111917 · Received November 18, 2016

    Report

    Report Number
    2024168-2016-08081
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    January 1, 2016
    Report Date
    November 17, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT AND IMPLANT DATE ESTIMATED. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD OF COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF OCCLUSION AND THROMBOSIS ARE LISTED IN THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE, (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH USE OF SUTURE MEDIATED CLOSURE DEVICES. IT SHOULD BE NOTED THAT THE IFU STATES: THE DEVICE IS DESIGNED TO DELIVER MONOFILAMENT POLYPROPYLENE SUTURE TO CLOSE FEMORAL ARTERY PUNCTURE SITES FOLLOWING DIAGNOSTIC OR INTERVENTIONAL PROCEDURES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE. LITERATURE: A CASE OF COMPLICATIONS ASSOCIATED WITH HEMOSTATIC DEVICE (PROGLIDE) FOR BRACHIAL ARTERY.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED ON REVIEW OF LITERATURE: "A CASE OF COMPLICATIONS ASSOCIATED WITH HEMOSTATIC DEVICE (PROGLIDE) FOR BRACHIAL ARTERY." REVIEW IDENTIFIED THAT AN ARTERIOTOMY CLOSURE OF A LEFT BRACHIAL ARTERY WAS COMPLETED USING A PROGLIDE DEVICE AFTER A COMMON ILIAC STENTING INTERVENTIONAL PROCEDURE. REPORTEDLY, THE NEXT DAY THE RADIAL PULSE WAS WEAKENED. ULTRASONOGRAPHY SHOWED THROMBOTIC OCCLUSION OF THE LEFT BRACHIAL ARTERY. THE BRACHIAL ARTERY WAS REVASCULARIZED. AS THE NAME OF THE PHYSICIAN WAS NOT PROVIDED IN THE LITERATURE, IT IS UNKNOWN IF THE PHYSICIAN HAS BEEN TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765599 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention