BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1172051 · Received September 17, 2008

    Report

    Report Number
    3004939290-2008-00074
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), MYNX HAS NOT BEEN STUDIED IN PTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE IN THE VICINITY OF THE PUNCTURE SITE. IT IS FURTHER NOTED IN THE IFU THAT THE OPERATOR SHOULD CONFIRM VIA ARTERIOGRAM THAT THERE IS NO PRESENCE OF SIGNIFICANT PVD IN THE VICINITY OF THE PUNCTURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION, NOR WAS THE LOT NUMBER PROVIDED. BASED ON THE INFO PROVIDED, THE ROOT CAUSE OF THE INCIDENT IS MOST LIKELY DUE TO SIGNIFICANT PRESENCE OF PVD RESULTING IN THROMBUS FORMATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION OR PERFORM AS INTENDED PER IFU.

    Description of Event or Problem · 1

    PT WITH HISTORY OF HYPERTENSION AND PVD UNDERWENT A DIAGNOSTIC CATHETERIZATION VIA A 6 FRENCH PROCEDURAL SHEATH IN 2008. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND PLAVIX, AND PERI-PROCEDURE HEPARIN WAS ADMINISTERED. THE ACCESS SITE, NOTED TO HAVE SIGNIFICANT SCARRING, WAS IN THE RIGHT COMMON FEMORAL ARTERY. PROXIMAL TO THE ACCESS SITE WAS A CALCIFIED LESION VISIBLE VIA FLUOROSCOPY. AT THE END OF THE PROCEDURE A MYNX VASCULAR CLOSURE DEVICE WAS PREPPED AND DEPLOYED BY A PHYSICIAN CURRENTLY BEING PROCTORED TO BECOME A TRAINED MYNX OPERATOR. DURING THE MYNX DEPLOYMENT, OOZING WAS OBSERVED AT THE PUNCTURE SITE. THE MYNX DEVICE WAS SUCCESSFULLY DEPLOYED; HOWEVER THE PT REQUIRED ADDITIONAL MANUAL COMPRESSION TO ACHIEVE COMPLETE HEMOSTASIS. A ROUTINE POST PROCEDURAL ASSESSMENT OF PEDAL PULSES INDICATED REDUCED FLOW IN THE IPSILATERAL LEG, AND THE PT REQUIRED SURGERY TO RESTORE NORMAL FLOW. THE PHYSICIAN FELT THAT THE MYNX SEALANT MAY HAVE CONTRIBUTED TO THE FORMATION OF THROMBUS HOWEVER, THE PATHOLOGY REPORT INDICATED THROMBUS WAS REMOVED AND THERE WAS NO MENTION OF FOREIGN MATTER WAS MADE. THE PT TOLERATED THE PROCEDURE WELL AND NO FURTHER INCIDENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R HEPARIN