BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN VENOGRAM BALLOON CATHETER

    MDR report key: 3862556 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01685
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYG
    PMA / PMN Number
    K012225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE CATHETER WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE CATHETER INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT THE LEG WITH THE SYRINGE CONNECTION IS CUT OFF FROM THE REMAINING PORTION OF THE CATHETER. BALLOON INFLATION/DEFLATION COULD NOT BE TESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE BALLOON CATHETER WOULD NOT DEFLATE WHILE IN THE PATIENT. THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON BY APPLYING NEGATIVE PRESSURE WITH A SYRINGE, AND THE CATHETER HAD TO BE REMOVED USING FORCE. THE IMPLANT WAS COMPLETED USING A NEW BALLOON CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339075 ATTAIN VENOGRAM BALLOON CATHETER CATHETER, FLOW DIRECTED DYG MEDTRONIC, INC. 6215

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention