BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2260748 · Received September 22, 2011

    Report

    Report Number
    3004939290-2011-00209
    Event Type
    Injury
    Date Received
    September 22, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND THE PROCEDURAL SHEATH WERE NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND WITHOUT A RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED.THE REVIEW OF THE LHR (LOT F1112404) 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 THAT A MALE PATIENT UNDERWENT A PERIPHERAL INTERVENTION PROCEDURE ON (B)(6) 2011. ACCESS WAS OBTAINED VIA A 7F PROCEDURAL SHEATH AT THE LEFT COMMON FEMORAL ARTERY (LCFA) VIA CONTRALATERAL ACCESS. PERI-PROCEDURE, AN ANTICOAGULANT (HEPARIN) WAS ADMINISTERED TO THE PATIENT AND THE PATIENT'S ACT WAS 270. A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED PRESENCE OF CALCIFICATION IN THE VICINITY OF THE ACCESS SITE AND THE STICK LOCATION AT THE MID FEMORAL HEAD. FOLLOWING THE PROCEDURE, THE DEPLOYER WHO IS A RADIOLOGY TECHNOLOGIST (RT) AND A TRAINED USER OF THE MYNX, WITH THE ACI SALES PROFESSIONAL PRESENT, USED THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. IT WAS REPORTED THAT THE RT INSERTED THE DEVICE AND INFLATED THE BALLOON. DURING DEVICE PULLBACK TOWARDS THE ARTERIOTOMY, A BALLOON RUPTURE OCCURRED. THE RT REMOVED THE DEVICE AND MANUAL PRESSURE WAS HELD FOR OVER 25 MINUTES AT THE ACCESS SITE FOLLOWED BY APPLICATION OF A FEMOSTOP. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS AMBULATED AND DISCHARGED PER HOSPITAL PROTOCOL WITH NO REPORTED CLINICAL SEQUELA. IT WAS REPORTED THAT THERE WERE MULTIPLE SHEATH EXCHANGES DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6701 F1112404

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN (NUMBER OF UNITS UNKNOWN)