BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 1885121 · Received October 28, 2010

    Report

    Report Number
    3005099803-2010-04398
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, EXPIRATION AND MANUFACTURING DATES CANNOT BE DETERMINED. PATIENT - HOSPITALIZATION REQUIRED. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT HAS BEEN DISPOSED OF AND THE DEVICE WILL NOT BE RETURNED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, IT WAS REPORTED THAT A MALFUNCTION OCCURRED. ADDITIONAL FOLLOW UP WITH THE PHYSICIAN REPORTED THAT A FLUID LOSS ALARM ERROR MESSAGE OCCURRED NINE AND A HALF MINUTES INTO THE ABLATION PHASE OF THE PROCEDURE. A CERVICAL LEAK DID NOT OCCUR. A UTERINE PERFORATION AND SUBSEQUENT BOWEL PERFORATION OCCURRED WHICH WAS CONFIRMED TO BE CAUSED BY THE HTA SHEATH. THE PROCEDURE WAS ABORTED AS A RESULT OF THE UTERINE AND BOWEL PERFORATION. ON (B)(6) 2010, THE PATIENT RETURNED DUE TO ABDOMINAL PAIN AND WAS ADMITTED TO THE HOSPITAL WHERE IT WAS NOTICED THAT THE PATIENT HAD SUSTAINED A BURN TO THE JUNCTION OF THE DISTAL JEJUNUM AND PROXIMAL ILEUM OF THE BOWEL. WHILE HOSPITALIZED, AS TREATMENT TO THE BOWEL PERFORATION AND BURN, A SURGEON PERFORMED A REANASTOMOSIS (A PROCEDURE IN WHICH THE HOLE IN THE BOWEL IS CUT OUT, AND THE REMAINING SEGMENTS ARE SURGICALLY REATTACHED) AND A SMALL BOWEL RESECTION. A DIAGNOSTIC LAPAROSCOPY WITH EXPLORATORY LAPAROTOMY WAS ALSO PERFORMED. THE BURN TO THE BOWEL WAS THIRD DEGREE IN SEVERITY AND THE APPROXIMATE SIZE IS UNKNOWN. THE UTERINE PERFORATION WAS ALLOWED TO HEAL ON ITS OWN WITHOUT ANY TREATMENT ADMINISTERED. IT WAS REPORTED THAT THE UTERINE AND BOWEL PERFORATION WERE EACH APPROXIMATELY THE SAME SIZE AS THE HTA HYSTEROSCOPE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 AND RELEASED (B)(6) 2010. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT AND THE CONDITION OF THE PATIENT IS REPORTED TO BE STABLE. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN PATIENT FOLLOW UP DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006560210

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R