BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 2143353 · Received June 29, 2011

    Report

    Report Number
    2210968-2011-00839
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ETHICON
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THERE WERE NO VISUAL DEFECTS FOUND. THE CATHETER PASSED THE LEAK TEST. THE DEVICE WAS ABLE TO MAINTAIN PRESSURE.

    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 PHYSICIAN WAS MAINTAINING PRESSURE INSIDE THE BALLOON CATHETER AT SEVEN MINUTES INTO THE EIGHT MINUTE CYCLE. THE PRESSURE THEN INCREASED ON THE MACHINE AND THE BALLOON POPPED. THE DOCTOR REMOVED THE BALLOON CATHETER AND THERE WAS A DEFICIT OF SEVEN CC'S. THE DOCTOR ENDED THE PROCEDURE AFTER THE SEVEN MINUTES. A HYSTEROSCOPY WAS DONE, AND THE PATIENT APPEARED TO BE FINE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PATIENT REPORTED THAT SHE WAS DOING FINE DURING A POST-OP PHONE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER,BALLOON,TRANSCERVICAL MNB ETHICON NA BHMG07

    Patients

    Seq Age Sex Outcome Treatment
    1