BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2032839 · Received March 29, 2011

    Report

    Report Number
    3004939290-2011-00036
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER SHAFT, ADVANCER TUBE AND SHUTTLE CARTRIDGE WERE NOT RETURNED. THE CORE WIRE WAS CUT AND RETURNED IN TWO SEPARATE PIECES. VISUAL INSPECTION REVEALED THAT THE BALLOON PROXIMAL BOND WAS DETACHED AND THE DISTAL BALLOON WAS INVERTED AND BUNCHED UP. THE BALLOON PROXIMAL BOND WAS FREE OF DAMAGE. BASED ON THE INFORMATION PROVIDED, THE CONDITION OF THE RETURNED DEVICE AND MISSING COMPONENTS, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1027101) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A MALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2011. ACCESS WAS OBTAINED VIA A 5F PROCEDURAL SHEATH AT THE COMMON FEMORAL ARTERY (CFA). A PRE-PROCEDURAL FEMORAL ANGIOGRAM SHOWED THAT THE FEMORAL ARTERY WAS CALCIFIED AND THE TISSUE TRACT WAS HIGHLY SCARRED. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. THERE WAS NO INFORMATION PROVIDED REGARDING THE STEPS PERFORMED IN THE DEPLOYMENT OF THE DEVICE. HOWEVER, POST DEPLOYMENT, THE DEVICE WAS REPORTEDLY "STUCK" AND THE PHYSICIAN WAS UNABLE TO REMOVE THE DEVICE FROM THE ARTERIOTOMY. SEVERAL SYRINGES AND ACCESS NEEDLES WERE USED TO ATTEMPT TO DEFLATE THE DEVICE BUT WITHOUT SUCCESS. REPORTEDLY, THE PHYSICIAN ENDED UP CUTTING THE CATHETER AND UTILIZED A NEEDLE OVER WHAT WAS LEFT OF THE WIRE TO TRY TO PUNCTURE THE BALLOON. REPORTEDLY, THE PHYSICIAN ENDED UP SHEARING OFF THE BALLOON AND SUBSEQUENTLY LODGING THE BALLOON IN THE PATIENT'S ILIAC ARTERY. THE PATIENT WAS TO BE SENT TO SURGERY WHEN THE VASCULAR SURGEON (VS) STANDING BY USED A CATHETER AND ATTEMPTED TO SNARE THE BALLOON FROM A CONTRALATERAL APPROACH. THE VS BURST THE BALLOON INTERNALLY AND USING THE CATHETER, WAS ABLE TO RETRACT THE BALLOON AND THE DEVICE WAS REMOVED SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX5000 F1027101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention