BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840280 · Received May 14, 2012

    Report

    Report Number
    3004939290-2012-00102
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 24, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE DEVICE SHOWED THAT THE SEALANT WAS FLARED OVER THE BALLOON PROXIMAL BOND. THE BALLOON HAD A SEVERELY INVERTED TIP. THE INVERTED BALLOON INDICATES SIGNIFICANT TENSION WAS APPLIED DURING PULL BACK. THE DEVICE WAS INFLATED WITH FLUID TO DETERMINE IF THERE WAS ANY PRESENCE OF A LEAK IN THE BALLOON OR ANY PART OF THE CATHETER; NO LEAK WAS OBSERVED. BASED ON THE INFO PROVIDED, THE CONDITION OF THE RETURNED DEVICE, AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE DEVICE PULL THROUGH WAS DETERMINED TO BE FROM EXCESSIVE TENSION APPLIED TO THE DEVICE. OVER TENSIONING THE DEVICE WHEN PULLING BACK THE SHEATH CAN CAUSE THE BALLOON TO PULL THROUGH THE ARTERIOTOMY. THE REVIEW OF THE LHR (F1127012) INDICATED THAT THE DEVICE 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 MALE PT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE MID FEMORAL ARTERY. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE TO BE APPROXIMATELY 5 MM. FOLLOWING THE PROCEDURE, THE DEPLOYER USED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 6F/7F FOR FEMORAL ARTERIAL CLOSURE. IT WAS REPORTED THAT A BALLOON PULL-THROUGH OCCURRED WITH LOSS OF PRESSURE. THE PHYSICIAN CONVERTED THE PT TO 15 MINUTES OF MANUAL COMPRESSION. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PT WAS AMBULATED AND DISCHARGED TO HOME THE NEXT DAY ((B)(6) 2012), WITH NO REPORTED CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6700 F1127012

    Patients

    Seq Age Sex Outcome Treatment
    1 HEPARIN