BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2822436 · Received June 27, 2012

    Report

    Report Number
    3004939290-2012-00170
    Event Type
    Injury
    Date Received
    June 27, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 29, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACI SALES PROFESSIONAL CONDUCTED A VISUAL INSPECTION OF THE DEVICE ONCE IT WAS OUTSIDE OF THE PT, AND OBSERVED THE SHEATH TO BE SEVERELY DAMAGED AND THE CARTRIDGE NOT MAKING CONTACT WITH THE BALLOON. THE SHEATH AND THE DEVICE WERE THROWN AWAY BEFORE THE SALES PROFESSIONAL COULD COLLECT THEM AND SEND TO THE MANUFACTURER FOR A COMPLETE INVESTIGATION. THE DEVICE AND THE PROCEDURAL SHEATH WERE NOT RETURNED; THEREFORE, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED AND NO RETURNED DEVICE, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1212902) INDICATED THAT THE MYNX LOT 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 PT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY, VIA A 6F TERUMO PINNACLE SHEATH. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM I THE VICINITY OF THE ACCESS SITE, AND THE VESSEL SIZE TO BE APPROXIMATELY 8 MM. PERI-PROCEDURE THE PT WAS ANTICOAGULATED WITH HEPARIN. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT AFTER THE PHYSICIAN "SHUTTLED THE SEALANT, THE SHEATH WOULD NOT RETRACT DUE TO THE DEVICE BEING JAMMED". THE PHYSICIAN CONTINUED TO ATTEMPT RETRACTION OF THE SHEATH AND THE BALLOON PULLED THROUGH THE ARTERIOTOMY. THE PT WAS GIVEN PROTAMINE FOR HEPARIN REVERSAL. THE PHYSICIAN REMOVED THE DEVICE AND CONVERTED THE PT TO 15 MINUTES OF MANUAL COMPRESSION, AND A FEMOSTOP WAS APPLIED FOR 2 HOURS, WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 F1212902

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention HEPARIN| PROTAMINE