BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1923999 · Received December 14, 2010

    Report

    Report Number
    3004939290-2010-00133
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROXIMAL AND DISTAL SEGMENT OF THE CORE WIRE AND BALLOON WERE RETURNED IN 2 SEPARATE PIECES. THE CATHETER, ADVANCER TUBE AND SHUTTLE CARTRIDGE WERE NOT RETURNED. VISUAL INSPECTION REVEALED THAT THE BALLOON PROXIMAL BOND WAS DETACHED AND THE DISTAL BALLOON SHAFT WAS INVERTED. THE BALLOON WAS STILL PARTIALLY INFLATED INDICATING THAT THE PROXIMAL BOND DETACHMENT OCCURRED WHILE THE BALLOON WAS STILL INFLATED. BASED ON THE CONDITION OF THE RETURNED COMPONENTS, AND WITHOUT THE COMPLETE DEVICE RETURNED, IT IS UNKNOWN IF THE WIRE DETACHMENT OCCURRED DURING PROCEDURE OR DUE TO SUBSEQUENT USER MANIPULATION. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER OF NOTE, IT WAS ASSESSED BY THE USER FACILITY THAT THE CAUSE OF THE EVENT COULD HAVE BEEN DUE TO THE INTERACTION OF THE MYNX DEVICE AND THE PREVIOUSLY PLACED STARCLOSE DEVICE IN THE VICINITY OF PUNCTURE. IT WAS REPORTED THAT THE PHYSICIAN DID NOT REALIZE HE MAY HAVE STUCK A STARCLOSE ALREADY IN THE ARTERIOTOMY. IT WAS OBSERVED THAT THE MYNX WENT THROUGH THE MIDDLE OF THE STARCLOSE AND WAS WRAPPED AROUND THE BALLOON AND THAT THE BALLOON WAS STILL INFLATED. THE REVIEW OF THE LHR (LOT F1021501) 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 (B)(6) MALE PATIENT WITH HISTORY OF PREVIOUS CATHETERIZATION UNDERWENT A CORONARY HEART CATHETERIZATION ON (B)(6) 2010. ACCESS WAS OBTAINED VIA A 6F PROCEDURAL SHEATH AT THE COMMON FEMORAL ARTERY. THE PHYSICIAN, A TRAINED USER OF THE MYNX, CHOSE THE DEVICE TO CLOSE THE FEMORAL ARTERY AFTER THE PROCEDURE. A FEMORAL ANGIOGRAM DID NOT REVEAL ANY CALCIUM AT THE VICINITY OF THE ACCESS SITE. THERE WAS NO INFORMATION PROVIDED REGARDING THE STEPS FOLLOWED IN THE DEPLOYMENT OF THE MYNX. REPORTEDLY, AFTER THE DEVICE WAS DEPLOYED, THE PHYSICIAN WAS UNABLE TO REMOVE THE DEVICE FROM THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN DID NOT REALIZE THAT HE MAY HAVE INSERTED THE PROCEDURAL SHEATH THROUGH A STARCLOSE ALREADY IN THE ARTERIOTOMY FROM A PREVIOUS CATHETERIZATION. THE CATH LAB STAFF CALLED THE ACI SALES PROFESSIONAL AT THIS POINT AND HE INSTRUCTED THEM TO PUT CONTRAST IN THE BALLOON FOR VISUALIZATION BUT THEY STILL COULD NOT SEE IT. THEY THOUGHT THE BALLOON HAD RUPTURED. THE PHYSICIAN TRIED TO PULL OUT THE DEVICE AGAIN TO NO AVAIL. A VASCULAR SURGEON WAS CALLED AND LOOKED AT THE DEVICE. HE ORDERED THE PATIENT INTO SURGERY AND DISSECTED THE ARTERY TO REMOVE THE BALLOON. IT WAS OBSERVED THAT THE MYNX WENT THROUGH THE MIDDLE OF THE STARCLOSE AND WAS WRAPPED AROUND THE BALLOON AND THAT THE BALLOON WAS STILL INFLATED. THE VASCULAR SURGEON PERFORMED A CUT DOWN AND REMOVED BOTH THE MYNX BALLOON AND STARCLOSE AND THEN PROCEEDED TO REPAIR THE ARTERY. THE TISSUE WAS SENT TO PATHOLOGY. THE PATIENT TOLERATED THE PROCEDURE WELL AND IS REPORTEDLY DOING FINE. IT WAS ALSO REPORTED THAT THE PATIENT WOULD MOST LIKELY REMAIN IN THE HOSPITAL OVERNIGHT. NO DISCHARGE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1021501

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention