BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 1571690 · Received January 5, 2010

    Report

    Report Number
    2210968-2009-01494
    Event Type
    Malfunction
    Date Received
    January 5, 2010
    Date of Event
    November 27, 2009
    Report Date
    December 1, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS REC'D, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6) 2009. DURING THE PROCEDURE, AFTER THE CATHETER WAS INTRODUCED, THERE WAS HEATING AND PRESSURE VARIATION, FOLLOWED BY AN ERROR CODE 19. THE PROCEDURE WAS RESTARTED AND THE PRESSURE DROPPED. WHEN THE CATHETER WAS REMOVED, THE BALLOON WAS FOUND TO BE PERFORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA AJMG03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK