BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIO-SEAL CLOSURE DEVICE

    MDR report key: 20566285 · Received October 29, 2024

    Report

    Report Number
    MW5161848
    Event Type
    Other
    Date Received
    October 29, 2024
    Date of Event
    October 22, 2024
    Report Date
    October 28, 2024
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) WAS NOTIFIED OF THE ADVERSE EVENT DESCRIBED BELOW. AFTER EVALUATING THE INFORMATION RECEIVED; (B)(6) HAS DETERMINED THE ADVERSE EVENT WAS NOT RELATED TO A DEVICE MANUFACTURED, SOLD, OR IMPORTED BY (B)(6). FOLLOWING 21CFR803.22, WE ARE HEREBY SUBMITTING (B)(6) NOTIFICATION OF THE EVENT TO CDRH. AS REPORTED BY THE (B)(6) FIELD CLINICAL SPECIALIST, AFTER SUCCESSFUL IMPLANT OF A SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC THE PROGLIDE AND ANGIOSEAL FAILED. VASCULAR INTERVENTION BY WIRE AND BALLOON WAS PERFORMED DUE TO PARTIAL SFA OCCLUSION. THERE WAS NO ALLEGATION OF ANY (B)(6) DEVICE THAT CAUSED THE EVENT. REFERENCE REPORT MW5161847. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066468 ANGIO-SEAL CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SAPIEN 3 ULTRA RESILIA VALVE.