BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 2113798 · Received May 17, 2011

    Report

    Report Number
    3004066202-2011-00021
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    INVATEC INNOVATIVE TECHNOLOGIES, SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS AND CONCLUSION: 80% STENOSIS, CALCIFICATION. EVAL SUMMARY: THE BALLOON HAS A 50MM LONGITUDINAL CUT.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE THE AMPHIRION DEEP PTA BALLOON CATHETER TO TREAT A DIFFUSE LESION LOCATED IN THE ANTERIOR TIBIAL AND POSTERIOR TIBIAL ARTERY WHICH EXHIBITED 80% STENOSIS AND CALCIFICATION. NO ABNORMALITIES WERE NOTED DURING PREPARATION OF THE RELEVANT DEVICE AND INSPECTION PRIOR TO USE; HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED LITTLE RESISTANCE AT THE TIME OF BALLOON INSERTION, STRONG FRICTION WITH THE GUIDE WIRE AND MILD FRICTION WITH THE GUIDE CATHETER. IT WAS ALSO REPORTED THAT THE BALLOON OF THE AMPHIRION DEEP DEVICE RUPTURED ON FIRST INFLATION AT 6ATMS. ANOTHER AMPHIRION DEEP WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO HEALTH HAZARD WAS CAUSED TO THE PT. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPHIRION DEEP PTA BALLOON CATHETER DQY INVATEC INNOVATIVE TECHNOLOGIES, SPA NA 1B030301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK