BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 2123878 · Received June 14, 2011

    Report

    Report Number
    2210968-2011-00765
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    March 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ETHICON
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED AND PERFORMED ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THERMAL ABLATION PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE BALLOON COULD NOT HOLD PRESSURE. THE PRESSURE DROPPED QUICKLY TWO MINUTES INTO THE THERAPY CYCLE. THE DEVICE WAS REMOVED FROM THE PATIENT IMMEDIATELY. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. THE NURSE BELIEVED THERE WAS A HOLE IN THE BALLOON. NO FLUID DEFICIT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER,BALLOON,TRANSCERVICAL MNB ETHICON NA CKMG08

    Patients

    Seq Age Sex Outcome Treatment
    1