BEUDAMED
    FDA Adverse Event Other Summary report: N

    MANTA VASCULAR CLOSURE DEVICE

    MDR report key: 20565857 · Received October 28, 2024

    Report

    Report Number
    MW5161834
    Event Type
    Other
    Date Received
    October 28, 2024
    Date of Event
    October 11, 2024
    Report Date
    October 23, 2024
    Manufacturer
    ESSENTIAL MEDICAL INC./HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V. (A TELEFLEX MEDICAL COMPANY)
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AS REPORTED BY FIELD CLINICAL SPECIALIST, THE MANTA WAS BEING USED TO CLOSE THE RFA. AFTER DEPLOYMENT UNABLE TO GET HEMOSTASIS. ATTEMPTED TO BALLOON TAMPONADE UNSUCCESSFUL. MD DECIDED TO CUT DOWN THE RFA TO REPAIR. PATIENT IN RECOVERY IN STABLE CONDITION. THE PATIENT WAS ALIVE AT THE END OF THE PROCEDURE. THE VALVE WAS SUCCESSFULLY IMPLANTED. THERE WAS NO CENTRAL LEAK. THE INITIAL REPORTER (E.G., PHYSICIAN, NURSING STAFF) DID NOT ALLEGE THE EW DEVICE WAS DEFICIENT IN ANY WAY. THERE WAS NO ALLEGATION THE (B)(6) SHEATH NEGATIVELY INTERACTED WITH THE MANTA DEVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR MW5161834 ON NOVEMBER 27TH, 2024 TO CHANGE THE NAME OF THE MANUFACTURER. ESSENTIAL MEDICAL INC./HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V. (A TELEFLEX MEDICAL COMPANY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034205 MANTA VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ESSENTIAL MEDICAL INC./HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V. (A TELEFLEX MEDICAL COMPANY)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown