BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTA 14F

    MDR report key: 15427617 · Received September 15, 2022

    Report

    Report Number
    3010252479-2022-00375
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 12, 2022
    Manufacturer
    ESSENTIAL MEDICAL, INC
    Product Code
    MGB
    UDI-DI
    00856279007079
    PMA / PMN Number
    P180025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE UNITS WERE RETURNED BY THE ACCOUNT FOR 2 MDRS. THE FOLLOWING WAS NOTED: 1 SHEATH, 1 MANTA ,1 DILATOR AND 1 PUNCTURE LOCATOR WERE RETURNED. BLOOD PARTICULATES WERE NOTED ON ALL UNITS. BUTTON VALVE OF THE SHEATH WAS PIERCED AND DISPLACED. MANTA LEVER WAS NOT ENGAGED . COMPONENTS PRESENT WITHIN THE LUMEN. LUMEN HAD MINOR DAMAGES. UNABLE TO REMOVE BYPASS TUBE FROM THE MANTA LUMEN. 1 DILATOR, 1 PUNCTURE LOCATOR AND 2 MANTAS WERE RETURNED. ONE OF THE MANTA UNIT LEVER AS NOT ENGAGED. KINKS COULD NOTED ON THE LUMEN. THE OTHER MANTA WAS LOCKED INTO THE SHEATH WITH THE LEVER ENGAGED. COMPONENTS (COLLAGEN, LOCK AND ANCHOR) WERE NOT PRESENT. THE DEVICE LOT HISTORY RECORD REVIEW INDICATED NO NON-CONFORMITIES RELATED TO THIS LOT, THEREFORE, SUPPORTING THE DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. FOLLOWING A TAVR PROCEDURE, A 14F MANTA WAS PLANNED FOR CLOSURE. DURING DEPLOYING THE DEVICE, AS REPORTED IN THE INCIDENT DESCRIPTION BY THE CUSTOMER, THE VALVE MALFUNCTIONED BECAUSE IT WAS NOT FORMED PROPERLY. DURING THE RETURN DEVICE EVALUATION, THE VALVE WAS NOTED TO BE PIERCED AND DISPLACED, NO EVIDENCE OF DEFORMATION WAS SEEN. WHILE ATTEMPTING TO INSERT THE BYPASS TUBE THROUGH THE HEMOSTATIC VALVE OF THE MANTA SHEATH, THE BYPASS TUBE MET WITH RESISTANCE AND WOULD NOT ADVANCE INTO THE SHEATH. THE IFU INDICATES IN STEP 3 OF INSERTING THE DEVICE: NOTE: IF SIGNIFICANT RESISTANCE IS FELT INSERTING THE BYPASS TUBE INTO THE MANTA SHEATH, REMOVE THE ENTIRE SYSTEM AND OPEN A NEW DEVICE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN OPENED TO REVIEW DEVICE HISTORY RECORD AND RISK DOCUMENTATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED: PER THE CUSTOMER, THE VALVE MALFUNCTIONED BECAUSE IT WAS NOT FORMED PROPERLY. ADDITIONAL INFORMATION ON (B)(6) 2022: 78 Y/O FEMALE WITH HISTORY OF SEVERE AORTIC STENOSIS. PROCEDURE: TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE VALVE OF THE MANTA WAS DEFORMED CAUSING THE MANTA TO NOT WORK PROPERLY. THIS MADE IT SO THE MANTA CLOSURE DEVICE WOULD NOT MOVE INTO THE SHEATH. 2 DEVICES USED WITHOUT SUCCESS. AN ANGIOSEAL CLOSURE DEVICE WAS SUCCESSFULLY USED ON THE THIRD ATTEMPT. NO KNOWN HARM TO PATIENT. PATIENT DISCHARGED NEXT DAY. ASSOCIATED TO MDR 3010252479-2022-00376 MANTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522389 MANTA 14F VASCULAR CLOSURE DEVICE MGB ESSENTIAL MEDICAL, INC 2156 MN2201433 00856279007079

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention