BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMACHOICE

    MDR report key: 1053106 · Received May 28, 2008

    Report

    Report Number
    2210968-2008-00366
    Event Type
    Death
    Date Received
    May 28, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 A THERMAL ENDOMETRIAL ABLATION PROCEDURE IN 2008. IN THE NEXT DAY, THE PT UNDERWENT PERITONEAL DIALYSIS TREATMENT, DEVELOPED SYMPTOMS OF SEPSIS, AND WAS TRANSFERRED TO THE HOSP INTENSIVE CARE UNIT. THE DIALYSATE WAS CULTURED AND FOUND TO BE POSITIVE FOR BETA-HEMOLYSIN STREPTOCOCCUS GROUP A. THE PT WAS DIAGNOSED WITH PERITONITIS AND SEPSIS AND WAS GIVEN AFTRIAXON AND CLONT. ABOUT A WEEK BEFORE PROCEDURE, A LAPAROTOMY AND HYSTERECTOMY WERE PERFORMED. THREE DAYS POST-PROCEDURE, THE PT EXPIRED. THE OFFICIAL CAUSE OF DEATH IS REPORTED AS SEPSIS. THE SURGEON OPINES THAT THE SEPSIS WAS CONTRIBUTED TO BY THE PERITONEAL DIALYSIS AND THE PT'S MORBID OBESITY. THE SURGEON AND THE HOSP OPINE THAT THE DEVICE DID NOT CONTRIBUTE TO THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA ABMG11

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H| L| R