BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21552563 · Received March 7, 2025

    Report

    Report Number
    2024168-2025-02429
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    January 23, 2025
    Report Date
    March 7, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT REPORTED. A REVIEW OF THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS NOT PERFORMED BECAUSE A SPECIFIC FAILURE MODE FOR THIS COMPLAINT WAS NOT PROVIDED. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY WAS NOT PERFORMED AS A SIMILARITY COULD NOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED UNSPECIFIED DEVICE ISSUE COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4- A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN. D4 AND H4: THE DEVICE EXPIRATION AND MANUFACTURING DATES COULD NOT BE PROVIDED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED. ATTACHMENT MEDWATCH REPORT # MW5165591.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES, ¿PERCLOSE DEVICE FAILURE AFTER SHEATH REMOVAL. PATIENT'S RIGHT GROIN HAD TO BE MANUALLY HELD FOR 30MINS AND FEMSTOP APPLIED. 3 OTHER PERCLOSE DEVICES WERE SUCCESSFULLY USED AFTERWARDS. WE WERE UNABLE TO DETERMINE WHICH OF THE 4 PERCLOSE DEVICES FAILED: LOT: 12773-03, REF: 4101743, LOT: 12773-03, REF: 4110141, LOT: 12773-03, REF: 4110141, LOT: 12773-03, REF: 4110141." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213232 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention