BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 2093341 · Received April 19, 2011

    Report

    Report Number
    3004066202-2011-00017
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 5, 2011
    Report Date
    March 21, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL: RESULTS, CONCLUSION: (ROOT CAUSE OF THE EVENT CANNOT BE CONFIRMED BASED ON LIMITED INFO AVAILABLE).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE AN AMPHIRION DEEP PTA CATHETER TO PRE-DILATE A FOCAL LESION WITH 95% STENOSIS IN THE POPLITEAL ARTERY. IT WAS REPORTED THE BALLOON OF THE AMPHIRION DEEP PTA CATHETER BURST WHEN INFLATED TO 6 ATMS. THE PHYSICIAN THEN USED ANOTHER PTA BALLOON CATHETER, HOWEVER THIS BALLOON RUPTURED AT 8 ATMS. AN ATTEMPT WAS MADE TO PULL BACK THE SECOND DEVICE; HOWEVER IT WAS REPORTED THAT DURING THIS ATTEMPT, THE BALLOON DETACHED FROM THE DELIVERY SYSTEM AND REMAINED IN THE PT. THE PT WAS SENT TO SURGERY. THE PT IS REPORTED TO BE FINE AND NO OTHER 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK