BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840257 · Received May 29, 2012

    Report

    Report Number
    3004939290-2012-00116
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 1, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE BALLOON WAS TORN. EXAM SHOWED A RADIAL TEAR AT THE BALLOON, APPROXIMATELY 3 MM FROM THE BALLOON PROXIMAL TIP. THE DISTAL TIP OF THE BALLOON WAS INVERTED. BASED ON THE INFO PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (F1135403) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. SEE MEDWATCH # 3004939290-2012-00115 FOR THE FIRST DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA AN UNK MODEL SHEATH. A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. POST PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON LOST PRESSURE. THE PHYSICIAN REMOVED THE DEVICE AND SINCE ACCESS WAS NOT LOST, THE PHYSICIAN PREPPED AND DEPLOYED A SECOND MYNX CADENCE VASCULAR CLOSURE DEVICE 6F/7F. THE SECOND DEVICE BALLOON ALSO LOST PRESSURE. THE PHYSICIAN REMOVED THE SECOND DEVICE AND CONVERTED THE PT TO 10 MINUTES OF MANUAL COMPRESSION. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY, WITH NO REPORTED CLINICAL SEQUELA. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6701 F1135403

    Patients

    Seq Age Sex Outcome Treatment
    1