BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYRDOTHERMABLATOR PROCEDURE SET

    MDR report key: 1051085 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00516
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT WAS DISPOSED OF; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. TWO POSSIBLE LOTS HAVE BEEN IDENTIFIED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THESE LOTS; NO EVIDENCE OF A MANUFACTURING - RELATED POTENTIAL CAUSE FOR THIS TYPE OF EVENT WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; NO SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR THESE LOTS. THE HTA USERS MANUAL INDICATES UTERINE PERFORATIONS ARE LISTED AS A POTENTIAL ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT (AGE, WEIGHT UNKNOWN) UNDERWENT A THERAPEUTIC HYDROTHERMAL ABLATION PROCEDURE IN 2008. APPROXIMATELY 30 SECONDS INTO THE HYSTEROSCOPY PHASE, THE PHYSICIAN NOTICED THAT THERE WAS A PERFORATION. ACCORDING TO COMPLAINANT, IT IS BELIEVED THAT THE PERFORATION WAS CAUSED BY EITHER THE SOUND OR THE DILATOR. THE PHYSICIAN INDICATED THAT THE PERFORATION WAS DUE TO THE STENOSIS OF THE CERVIX COUPLED WITH BICORNUATE UTERUS. THE PROCEDURE WAS ABORTED. NO TREATMENT WAS REQUIRED AND THE PHYSICIAN FELT THAT IT WOULD HEAL ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYRDOTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC M006560201 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other