BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPHIRION DEEP

    MDR report key: 2881756 · Received December 20, 2012

    Report

    Report Number
    3004066202-2012-00163
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 26, 2012
    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). RESULTS: BASED ON THE INFORMATION PROVIDED NO ROOT CAUSE CAN BE DETERMINED. DEVICE WAS NOT PURGED BEFORE USE. CONCLUSION: DEVICE WAS NOT PURGED BEFORE USE. BASED ON THE INFORMATION PROVIDED NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE AN AMPHIPRION DEEP PTA BALLOON CATHETER TO TREAT A PATIENT. THE DEVICE WAS INSPECTED BEFORE USE AND NO ABNORMALITIES WERE NOTED. NEGATIVE PREPARATION WAS NOT PERFORMED. THE BALLOON COULD NOT BE INFLATED. THE DEVICE WAS REMOVED AND A PINHOLE WAS FOUND ON THE BALLOON. NO PATIENT COMPLICATION WAS REPORTED. EVALUATION SUMMARY: THE DEVICE APPEARS USED. THE BALLOON WAS UNFOLDED. THE GUIDEWIRE LUMEN WAS FLUSHED BY CONNECTING A SYRINGE FILLED WITH WATER TO THE DEVICE HUB AND NO LEAKS WERE IDENTIFIED. A 0.014" GUIDEWIRE WAS INSERTED IN THE HUB OF THE CATHETER AND NO FRICTION WAS DETECTED. A MANOMETRIC SYRINGE FILLED WITH WATER WAS CONNECTED TO THE BALLOON LUMEN OF THE HUB AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON. A LEAK WAS DETECTED. THE DAMAGE ON THE BALLOON SURFACE IS CONFIRMED AS A BALLOON PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPHIRION DEEP CATHETER, PERCUTANEOUS DQY INVATEC SPA 1C025100

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR