BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPHIRION DEEP OTW

    MDR report key: 3151286 · Received June 7, 2013

    Report

    Report Number
    3004066202-2013-00089
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 29, 2013
    Report Date
    May 31, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULT: RELATED TO OPERATIONAL CONTEXT (OPERATOR'S TECHNIQUE OR HANDLING MAY HAVE CAUSED EVENT). CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT (OPERATOR'S TECHNIQUE OR HANDLING MAY HAVE CAUSED EVENT).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A LESION WITH ARTERY STENOSIS IN THE LEFT POSTERIOR TIBIAL ARTERY. THE AMPHIRION DEEP WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON THE DEVICE. THE LESION HAD NOT BEEN PRE-DILATED PRIOR TO THE ADVANCEMENT AND ATTEMPTED INFLATION OF THE AMPHIRION DEEP BALLOON. WHEN THE DEVICE REACHED THE LESION IT WAS FOUND THAT THE BALLOON COULD NOT BE INFLATED. NO RESISTANCE WAS ENCOUNTERED WHEN LOADING THE DEVICE ONTO THE GUIDE WIRE, THROUGH THE HAEMOSTATIC VALVE OR WHEN LOADING THE DEVICE INTO THE SHEATH. NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR EVALUATION. TRACES OF BLOOD AND RADIO OPAQUE SOLUTION WERE DETECTED ON THE DEVICE AND INTO THE SHAFT. ON INSPECTION THE BALLOON FOLDS WERE STUCK TOGETHER. AN ATTEMPT TO MADE TO INFLATE THE DEVICE BUT A LEAKAGE WAS DETECTED ON THE BALLOON. USING A MICROSCOPE THE BALLOON WAS ANALYZED AND A CUT WAS DETECTED ON THE SURFACE. THE SURFACE OF THE BALLOON NEAR THE CUT WAS SCRATCHED. A KINK WAS DETECTED AT 20 CM FROM THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252633 AMPHIRION DEEP OTW CATHETER, PERCUTANEOUS DQY INVATEC SPA 1D014574

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR