BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 2032061 · Received March 28, 2011

    Report

    Report Number
    2210968-2011-00359
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ETHICON, INC. - JUAREZ
    Product Code
    FTL
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/28/2011. (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/20/2011. CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE CATHETER FAILED THE LEAK TEST BECAUSE IT HAD TWO HOLES IN THE BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE AT 3 MINUTES AND 30 SECONDS INTO THE THERAPY CYCLE, THE DEVICE WOULD NOT MAINTAIN PRESSURE. THERE WAS A HOLE NOTED IN THE BALLOON WHEN IT WAS REMOVED. THE SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER,BALLOON,TRANSCERVICAL FTL ETHICON, INC. - JUAREZ NA CHMG08

    Patients

    Seq Age Sex Outcome Treatment
    1