BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTA 18F

    MDR report key: 13398397 · Received January 31, 2022

    Report

    Report Number
    3010252479-2022-00072
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    January 18, 2022
    Report Date
    January 18, 2022
    Manufacturer
    ESSENTIAL MEDICAL, INC
    Product Code
    MGB
    UDI-DI
    00856279007062
    PMA / PMN Number
    P180025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ONE 18F MANTA CLOSURE DEVICE, ONE MANTA SHEATH, AND ONE INTRODUCER WAS RETURNED FOR INVESTIGATION AND WAS RECEIVED. THE COMPONENTS WERE DECONTAMINATED THEN VISUALLY INSPECTED. DURING INSPECTION THE ENGINEER NOTED BLOOD PARTICULATES PRESENT ON ALL COMPONENTS. THE BUTTON VALVE WAS TORN AND COMPLETELY DISPLACED FROM ITS POSITION WITHIN THE SHEATH. THE MANTA LEVER WAS NOT ACTIVATED. 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. BASED ON THE INFORMATION SUBMITTED, FOLLOWING A TAVR PROCEDURE, A 18F MANTA WAS PLANNED FOR CLOSURE. NO ISSUES WERE ENCOUNTERED ADVANCING OR WITHDRAWING PROCEDURAL SHEATHS. WHILE INSERTING THE BYPASS TUBE THROUGH THE HEMOSTATIC VALVE OF THE MANTA SHEATH, THE PHYSICIAN ENCOUNTERED MODERATE TO SEVERE RESISTANCE WHILE ATTEMPTING TO ADVANCE THE BYPASS TUBE INTO THE SHEATH HUB. 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. ASSOCIATED TO FU-3010252479-2022-000723 MANTA.

    Description of Event or Problem · 0

    AS REPORTED: DOCTOR WENT TO INSERT BYPASS TUBE THROUGH THE MANTA SHEATH VALVE AND IT WOULD NOT GO. HE STRUGGLED A BIT AND ULTIMATELY ENDED UP OPENING A SECOND DEVICE. THE SECOND DEVICE WAS ALSO DIFFICULT BUT HE ULTIMATELY WAS ABLE TO DELIVER THE BYPASS TUBE THROUGH THE VALVE WITH FORCE. ASSOCIATED TO: MDR 3010252479-2022-00073 MANTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087868 MANTA 18F VASCULAR CLOSURE DEVICE MGB ESSENTIAL MEDICAL, INC 2115 MN2101395 00856279007062

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female