BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 2183011 · Received July 28, 2011

    Report

    Report Number
    2210968-2011-01019
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    (B)(6), CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE DEVICE WAS RECEIVED IN A CONDITION WHICH DOES NOT MEET SPECIFICATION. THE CATHETER FAILED THE LEAK TEST BECAUSE IT HAD TWO HOLES IN THE BALLOON. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THERMAL ABLATION ON AN UNKNOWN DATE. DURING THE THERAPY, THE BALLOON BURST. AT THIS TIME, THERE IS NO FURTHER INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER,BALLOON,TRANSCERVICAL MNB ETHICON, INC. NA DCMG04

    Patients

    Seq Age Sex Outcome Treatment
    1