BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTA 18F

    MDR report key: 15362155 · Received September 6, 2022

    Report

    Report Number
    3010252479-2022-00364
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    August 29, 2022
    Report Date
    August 29, 2022
    Manufacturer
    ESSENTIAL MEDICAL, INC
    Product Code
    MGB
    PMA / PMN Number
    P180025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    TWO 18F MANTA HANDLE UNITS, 2 18F SHEATHS, 2 18F INTRODUCERS, 1 BLUE ADVANCEMENT TUBE, AND 1 COLLAGEN PLUG (COLLAGEN, TOGGLE, RADIOPAQUE LOCK, AND SUTURE) WERE RETURNED. ONE MANTA HANDLE UNIT WAS LOCKED INTO THE SHEATH AND THE LEVER WAS COMPLETELY PULLED BACK; NO GUIDEWIRE LUMEN INCLUDED. THE OTHER 18F HANDLE UNIT DID NOT EXHIBIT THE LEVER IN THE ACTIVATED POSITION, DID NOT HAVE THE MANTA SHEATH ATTACHED, THE COLLAGEN PLUG COULD VISIBLY BE SEEN WITHIN THE BYPASS TUBE, AND THE GUIDEWIRE LUMEN STILL IN PLACE. BLOOD PARTICULATES WERE NOTED ON THE UNITS. THE LEVER WAS OBSERVED TO BE PULLED WITH THE COMPONENTS PUSHED OUTSIDE. 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, AN 18F MANTA WAS PLANNED FOR CLOSURE. PATIENT INFORMATION INDICATED A BMI OF 44.3. THE INSTRUCTIONS FOR USE WARNS NOT USE MANTA IF THE PATIENT HAS MARKED OBESITY (BMI >40 KG/M2). NO ISSUES WERE ENCOUNTERED ADVANCING OR WITHDRAWING THE PROCEDURAL SHEATHS. WHILE ATTEMPTING TO INSERT THE BYPASS TUBE THROUGH THE HEMOSTATIC VALVE OF THE MANTA SHEATH, THE BYPASS TUBE MET WITH SEVERE RESISTANCE. NO BUCKLING OR BENDING OCCURRED TO THE BYPASS TUBE WHEN MET WITH RESISTANCE. THE FIRST MANTA DEVICE WAS REMOVED, AND THE FIRST MANTA SHEATH REMAINED ON THE GUIDEWIRE. A SECOND 18F MANTA DEVICE WAS OPENED. THE PHYSICIAN WAS AGAIN UNABLE TO ADVANCE THE BYPASS TUBE THROUGH THE HEMOSTATIC VALVE OF THE MANTA SHEATH, THE BYPASS TUBE MET WITH SEVERE RESISTANCE. NO BUCKLING OR BENDING OCCURRED TO THE BYPASS TUBE WHEN MET WITH RESISTANCE. THE SECOND MANTA DEVICE AND FIRST MANTA SHEATH WERE REMOVED. A THIRD 18F MANTA DEVICE WAS OPENED, AND THE MANTA SHEATH FROM THE OPENED SECOND MANTA DEVICE WAS PLACED ON THE GUIDEWIRE. USING EXCESSIVE FORCE, THE PHYSICIAN ADVANCED THE THIRD 18F MANTA DEVICE INTO THE SHEATH HUB; AND WAS ABLE TO PENETRATE THE SHEATH VALVE, CLICKING THE CLOSURE HANDLE AND SHEATH HUB TOGETHER. FOLLOWING DEPLOYMENT, MINIMAL OOZING WAS PRESENT, MANUAL PRESSURE WAS APPLIED FOR FIVE MINUTES, SUCCESSFULLY ACHIEVING HEMOSTASIS. EXTENDED TIME TO HEMOSTASIS MAY OCCUR DUE TO COLLAGEN REQUIRING TIME TO CLOT TO CREATE A SEAL. POST-PROCEDURAL BLEEDING/OOZING IS A COMMON OCCURRENCE FOLLOWING ANY CLOSURE DEVICE DEPLOYMENT. ADDITIONALLY, MANUAL COMPRESSION TO ACHIEVE A QUICKER TIME TO HEMOSTASIS IS A CLINICALLY ACCEPTED THERAPY AND DOES NOT INDICATE DEVICE FAILURE. 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. PER PROCEDURE REQUIREMENTS, THE MANTA CLOSURE MUST BE DEPLOYED USING THE MANTA SHEATH PROVIDED IN THE MANTA PACKAGE; DO NOT SUBSTITUTE ANY OTHER SHEATH. POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ANY LARGE BORE INTERVENTION, INCLUDING THE USE OF THE MANTA VASCULAR CLOSURE DEVICE, INCLUDE BUT ARE NOT LIMITED TO: OOZING FROM THE PUNCTURE SITE. PRECAUTIONS IF BLEEDING FROM THE FEMORAL ACCESS SITE PERSISTS AFTER THE USE OF THE MANTA DEVICE, ASSESS THE SITUATION. BASED ON THE AMOUNT OF BLEEDING, USE MANUAL OR MECHANICAL COMPRESSION, APPLICATION OF BALLOON PRESSURE FROM A SECONDARY ACCESS SITE, PLACEMENT OF A COVERED STENT, AND/OR SURGICAL REPAIR TO OBTAIN HEMOSTASIS. ASSOCIATED TO 2 OTHER COMPLAINTS (B)(4) MANTA AND (B)(4) MANTA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THREE DEVICES WERE OPENED FOR ONE TAVR CASE. THE FIRST SHEATH WAS PLACED INTO THE ACCESS SITE. THE FIRST DEVICE WAS ATTEMPTED TO BE ADVANCED THROUGH THE VALVE OF THE FIRST SHEATH. THAT DEVICE WAS UNABLE TO BE ADVANCED THROUGH THE VALVE OF THE SHEATH. A SECOND PACKAGE WAS OPENED AND ATTEMPTED TO ADVANCE THIS DEVICE THROUGH THE EXISTING FIRST SHEATH. THEY WERE UNABLE TO ADVANCE THE SECOND DEVICE THROUGH THE FIRST SHEATH VALVE. A THIRD PACKAGE WAS OPENED. THEY CHANGED OUT THE FIRST SHEATH FOR THE OPENED SECOND SHEATH. THEY ADVANCED THE THIRD DEVICE INTO THE SHEATH. WITH EXCESSIVE FORCE, THEY WERE ABLE TO PENETRATE THE VALVE OF THE SHEATH UNTIL IT CLICKED. THE OUTCOME WAS SUCCESSFUL WITH THAT DEPLOYMENT. THEY HELD PRESSURE FOR 5 MINUTES AND HAD LITTLE TO NO OOZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368115 MANTA 18F VASCULAR CLOSURE DEVICE MGB ESSENTIAL MEDICAL, INC 2115 MN2201456

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female