BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 20237097 · Received September 17, 2024

    Report

    Report Number
    2124215-2024-57956
    Event Type
    Death
    Date Received
    September 17, 2024
    Date of Event
    August 16, 2024
    Report Date
    October 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953000626
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION UPDATED: B5: DESCRIBE EVENT/PROBLEM. H6: EVALUATION CONCLUSION CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ONE DAY AFTER THE IMPLANT PROCEDURE OF THIS ARTIFICIAL URINARY SPHINCTER (AUS), THE PATIENT EXPERIENCED SWELLING IN THE SCROTUM. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, DURING WHICH IT WAS NOTED THAT THE BALLOON HAD MIGRATED CEPHALICALLY, AND ONE DAY AFTER THE SCAN, AN INTESTINAL PERFORATION WAS CONFIRMED. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU); HOWEVER, FOUR DAYS LATER, THE PATIENT DIED FROM SEPSIS AND ASPIRATION. DURING THE ICU STAY, NO TREATMENT FOR THE INTESTINAL PERFORATION WAS REPORTED, AND NO SURGICAL INTERVENTION WAS PERFORMED. THE MEDICAL STAFF STATED THAT, DURING THE IMPLANT PROCEDURE, THE PUMP WAS NOT PROPERLY SECURED WITH ALLIS FORCEPS, CAUSING IT TO SIT IN AN UPWARD POSITION. THE PUMP TUBE WAS CUT WHILE IN THIS INCORRECT POSITION, LEADING TO A SHORTENED TUBE, WHICH WAS THEN CONNECTED TO THE CUFF AND BALLOON. AFTER THE CONNECTION, THE PUMP WAS REPOSITIONED LOWER IN THE SCROTUM, WHICH PULLED ON THE BALLOON, CAUSING IT TO ATTACH TO THE INTESTINAL TISSUE AND TEAR IT. IT WAS ALSO STATED THAT, AFTER ROBOTIC SURGERY FOR PROSTATE CANCER, PATIENT'S INTESTINAL TRACT MIGRATED AND ADHERED BELOW THE PUBIC BONE, WHERE THE BALLOON WAS INSERTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ONE DAY AFTER THE IMPLANT PROCEDURE OF THIS ARTIFICIAL URINARY SPHINCTER (AUS), THE PATIENT EXPERIENCED SWELLING IN THE SCROTUM. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, DURING WHICH IT WAS NOTED THAT THE BALLOON HAD MIGRATED CEPHALICALLY, AND ONE DAY AFTER THE SCAN, AN INTESTINAL PERFORATION WAS CONFIRMED. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU); HOWEVER, FOUR DAYS LATER, THE PATIENT DIED FROM SEPSIS AND ASPIRATION. DURING THE ICU STAY, NO TREATMENT FOR THE INTESTINAL PERFORATION WAS REPORTED, AND NO SURGICAL INTERVENTION WAS PERFORMED. THE MEDICAL STAFF STATED THAT, DURING THE IMPLANT PROCEDURE, THE PUMP WAS NOT PROPERLY SECURED WITH ALLIS FORCEPS, CAUSING IT TO SIT IN AN UPWARD POSITION. THE PUMP TUBE WAS CUT WHILE IN THIS INCORRECT POSITION, LEADING TO A SHORTENED TUBE, WHICH WAS THEN CONNECTED TO THE CUFF AND BALLOON. AFTER THE CONNECTION, THE PUMP WAS REPOSITIONED LOWER IN THE SCROTUM, WHICH PULLED ON THE BALLOON, CAUSING IT TO ATTACH TO THE TISSUE AND TEAR IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761086 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72400024 1100450922 00878953000626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| H