BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1821469 · Received August 31, 2010

    Report

    Report Number
    3004939290-2010-00099
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 5, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NARRATIVE STATES THAT THE DEVICE WAS CUT IN HALF IN AN ATTEMPT TO DEFLATE THE BALLOON. THE BALLOON SEGMENT WAS RECEIVED AND INVESTIGATED TO DETERMINE THE POSSIBLE CAUSE OF THE REPORTED BALLOON FAILURE TO DEFLATE. THE BALLOON SHAFT AND CORE WIRE SEGMENT WAS APPROXIMATELY 245MM. VISUAL INSPECTION REVEALED THAT THE BALLOON PROXIMAL BOND WAS DETACHED AND THE DISTAL BALLOON WAS INVERTED AND BUNCHED UP. DAMAGE WAS NOTED TO THE PROXIMAL BOND. THE CORE WIRE WAS EXPOSED AND WAS CUT APPROXIMATELY 220MM FROM THE CATHETER HANDLE. THE CATHETER, ADVANCER TUBE AND THE PROCEDURAL SHEATH WERE NOT RETURNED; THEREFORE, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. PER THE INFORMATION RECEIVED, IT WAS REPORTED THAT THE STAFF ASSESSED THIS TO BE DUE TO IMPROPER DEVICE REMOVAL. PER THE MYNX INSTRUCTIONS FOR USE (IFU) REMOVE DEVICE AS FOLLOWS: LOCK THE SYRINGE TO MAX NEGATIVE, APPLY LIGHT FINGERTIP COMPRESSION PROXIMAL TO THE INSERTION SITE, THEN LIGHTLY GRASP ADVANCER TUBE AT SKIN WITH THUMB AND FOREFINGER AND REALIGN WITH THE TISSUE TRACT, OPEN STOPCOCK TO DEFLATE THE BALLOON, TO ENSURE COMPLETE BALLOON DEFLATION, WAIT UNTIL AIR BUBBLES AND FLUID HAVE STOPPED MOVING THROUGH THE INFLATION TUBING, SLOWLY WITHDRAW BALLOON CATHETER THROUGH THE ADVANCER TUBE LUMEN. NOTE: IF UNUSUAL RESISTANCE IS FELT CURING CATHETER WITHDRAWAL, PULL THE ADVANCER TUBE AND BALLOON CATHETER TOGETHER THROUGH THE TISSUE TRACT. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, PRODUCT RELEASE AT ACI IS CONTINGENT UPON THE SUCCESSFUL COMPLETION OF LOT RELEASE TESTING AND A DOCUMENTATION REVIEW BY THE QUALITY DEPARTMENT.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE LHR (LOT #F1011002) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE ACI SALES PROFESSIONAL ON 08/05/10 THAT A PATIENT (PATIENT DETAILS NOT PROVIDED) UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE IN WHICH THE COMMON FEMORAL ARTERY (CFA) WAS ACCESSED VIA A 6F SHEATH. A PRE-PROCEDURE FEMORAL ANGIOGRAM WAS DONE HOWEVER THE RESULTS WERE NOT PROVIDED. THE RADIOLOGY TECHNICIAN (RT) TRAINED TO THE CLOSURE PROCEDURE, CHOSE THE MYNX DEVICE FOR CLOSING THE FEMORAL ARTERY. IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE DURING DEVICE REMOVAL. AFTER SEVERAL ATTEMPTS TO REMOVE, RE-ATTACH, AND PULL NEGATIVE ON THE SYRINGE THEY COULD NOT GET THE BALLOON TO DEFLATE SO THEY PROCEEDED TO CUT THE DEVICE IN HALF. THEY ALSO TRIED USING AN ACCESS NEEDLE TO DEFLATE THE BALLOON AND COULD NOT SUCCESSFULLY PUNCTURE THE BALLOON. THE PATIENT WAS TAKEN TO SURGERY. THE SURGEON PERFORMED A 3-INCH CUT DOWN AND 1 CM INCISION IN THE CFA. THE BALLOON WAS REMOVED SAFELY. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY FURTHER COMPLICATION. OF NOTE, THE HOSPITAL STAFF BELIEVE THE CAUSE OF THE DEVICE GETTING STUCK WAS DUE TO IMPROPER DEVICE REMOVAL PRIOR TO BALLOON DEFLATION AND NOT MYNX RELATED.

    Description of Event or Problem · 1

    SURGERY TYPE WAS AN ATHERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1011002

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention