BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTA 18F

    MDR report key: 16794457 · Received April 24, 2023

    Report

    Report Number
    3010252479-2023-00080
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 10, 2023
    Manufacturer
    ESSENTIAL MEDICAL, INC.
    Product Code
    MGB
    UDI-DI
    00856279007062
    PMA / PMN Number
    P180025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). AN INVESTIGATION HAS BEEN OPENED TO REVIEW HISTORICAL DATA AND RISK DOCUMENTATION. A FOLLOW UP REPORT WILL BE SUBMITTED AFTER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    QN#(B)(4) THREE MANTA POUCHES WERE RETURNED TOGETHER BY THE CUSTOMER FOR 3010252479-2023-00078 MANTA, 3010252479-2023-00079 MANTA AND 30102524 79-2023-00080 MANTA. BLOOD PARTICULATES WERE NOTED IN ALL THE UNITS. THE UNITS WERE DECONTAMINATED AND INSPECTED. POUCH 3 (3010252479-2023-00080 MANTA.): ONE UNIT OF MANTA, 2 DILATORS AND SHEATH WERE RETURNED. THE LEVER OF THE MANTA WAS NOT ENGAGED. NO DAMAGES OR TEAR NOTED ON THE BUTTON VALVE. MINOR DISPLACEMENT OF THE BUTTON VALVE WAS NOTED. THE UNIT WAS FUNCTIONAL TESTED FOR ADVANCEMENT. THE SHEATH WAS DILATED FOR 30S.RESISTANCE WAS OBSERVED UPON ADVANCING THE BYPASS TUBE. 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 TAVI PROCEDURE, AN 18F CE MANTA WAS PLANNED FOR CLOSURE. NO ISSUES WERE ENCOUNTERED ADVANCING OR WITHDRAWING THE PROCEDURAL SHEATHS. WHILE INSERTING THE BYPASS TUBE THROUGH THE HEMOSTATIC VALVE OF THE MANTA SHEATH, THE PHYSICIAN ENCOUNTERED "BIG" RESISTANCE ATTEMPTING TO ADVANCE THE BYPASS TUBE INTO THE SHEATH HUB. THE PHYSICIAN ATTEMPTED TO INSERT THE BYPASS TUBE INTO THE HEMOSTATIC VALVE MULTIPLE TIMES ALTHOUGH THE RESISTANCE CONTINUED. NO BUCKLING OR BENDING OCCURRED TO THE BYPASS TUBE WHEN MET WITH RESISTANCE. 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. FOR FURTHER INVESTIGATION, LOT REVIEW, AND OTHER TESTING. THE DER PROCESS WILL CONTINUE TO MONITOR FOR ANY SIMILAR EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "TAVI PROCEDURE, THE HUB(MEMBRANE) OF THE MANTA SHEATH WAS DEFECTED, THE DOCTOR TRIED TO INSERT THE MANTA TO THE SHEATH SEVERAL TIMES BUT FELT A BIG RESISTANCE (RELATED TO 3010252479-2023-00078 MANTA). HE TOOK ANOTHER MANTA DEVICE, AND THE PROBLEM WAS REPEATED (RELATED TO 3010252479-2023-00079 MANTA). SO HE HAD TO TAKE A THIRD MANTA AND THEN IT WAS OK. IT HAPPENED TWICE IN 2 DIFFERENT PATIENTS IN A ROW. 4 MANTA'S IN TOTAL WERE DEFECTED (CAPTURED IN 3010252479-2023-00081 MANTA). ADDITIONAL INFORMATION ON 18APR2023. THE ISSUE WAS IDENTIFIED DURING A TAVI PROCEDURE. THERE WERE NO ISSUES ADVANCING OR WITHDRAWING PROCEDURAL SHEATHS. WHEN RESISTANCE WAS MET, THE ENTIRE DEVICE WAS REMOVED, AND ANOTHER MANTA DEVICE WAS USED. THERE WAS NO BUCKLING OR BENDING OF THE BYPASS TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "TAVI PROCEDURE, THE HUB(MEMBRANE) OF THE MANTA SHEATH WAS DEFECTED, THE DOCTOR TRIED TO INSERT THE MANTA TO THE SHEATH SEVERAL TIMES BUT FELT A BIG RESISTANCE (RELATED TO 3010252479-2023-00078 MANTA). HE TOOK ANOTHER MANTA DEVICE, AND THE PROBLEM WAS REPEATED (RELATED TO 3010252479-2023-00079 MANTA). SO HE HAD TO TAKE A THIRD MANTA AND THEN IT WAS OK. IT HAPPENED TWICE - IN 2 DIFFERENT PATIENTS IN A ROW. 4 MANTA'S IN TOTAL WERE DEFECTED (CAPTURED IN 3010252479-2023-00080 MANTA AND 3010252479-2023-00081 MANTA). ADDITIONAL INFORMATION ON 18APR2023: THE ISSUE WAS IDENTIFIED DURING A TAVI PROCEDURE. THERE WERE NO ISSUES ADVANCING OR WITHDRAWING PROCEDURAL SHEATHS. WHEN RESISTANCE WAS MET, THE ENTIRE DEVICE WAS REMOVED, AND ANOTHER MANTA DEVICE WAS USED. THERE WAS NO BUCKLING OR BENDING OF THE BYPASS TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827387 MANTA 18F VASCULAR CLOSURE DEVICE MGB ESSENTIAL MEDICAL, INC. 2115NE MN2201483 00856279007062

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED| NOT REPORTED