BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAXESS CATHETER

    MDR report key: 129476 · Received October 31, 1997

    Report

    Report Number
    2951250-1997-00007
    Event Type
    Other
    Date Received
    October 31, 1997
    Date of Event
    October 1, 1997
    Report Date
    October 30, 1997
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HGS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A FALLOPOSCOPY PROCEDURE, THE COAXESS (TM) CATHETER PERFORATED THE UTERUS, APPROX 0.5 TO 1CM AWAY FROM THE TUBAL OSTIUM. NO MED INTERVENTION WAS REQUIRED. THE EVENT WAS FOLLOWED BY A PRESCHEDULED HYSTERECTOMY. THIS IS AN ANTICIPATED ADVERSE EVENT AS STATED IN PRODUCT LABELING. ADVERSE EVENT IS MARKED "OTHER" BECAUSE IT IS UNK WHETHER OR NOT THIS EVENT MAY RESULT IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAXESS CATHETER UTERINE CATHETER HGS CONCEPTUS, INC. SLU003 C02017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other LAPAROSCOPY AND HYSTEROSCOPY PERFORMED| SIMULTANEOUS TO FALLOPOSCOPY.