BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 7967533 · Received October 15, 2018

    Report

    Report Number
    2183959-2018-60203
    Event Type
    Injury
    Date Received
    October 15, 2018
    Date of Event
    August 24, 2018
    Report Date
    May 9, 2019
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FLUID LOSS WAS REPORTED. THE AMS800 PRESSURE REGULATING BALLOON WAS VISUALLY INSPECTED. THERE WAS A LEAK IN THE BALLOON SHELL THAT WAS THE RESULT OF BULGING, FATIGUE AND AVULSION. THE BALLOON WAS NOT FUNCTIONALLY TESTED DUE TO THE LEAK. REVIEW OF THE MANUFACTURING RECORDS FOR BATCH 152228 CONFIRMED THAT THERE WAS A TOTAL OF (B)(4) UNITS STARTED FOR THIS MANUFACTURED BATCH WITH 0 UNITS SCRAPPED. IT CAN BE CONCLUDED THAT ALL THE FINISHED GOODS COMPONENTS IN THIS BATCH WERE MANUFACTURED PER PROCESS AND MET ALL SPECIFICATIONS. A REVIEW OF THE SHIP HISTORY WAS NOT PERFORMED SINCE THE BATCH NUMBER WAS PROVIDED. A LABELING REVIEW WAS NOT PERFORMED AS THERE IS NO EVIDENCE THAT THE DEVICE WAS USED OR HANDLED IMPROPERLY. NO RISK REVIEW REQUIRED PER CIS PRODUCT INVESTIGATION WI, (B)(4). AN OVERALL INVESTIGATION CONCLUSION CODE OF "CAUSE TRACED TO COMPONENT FAILURE" WAS CHOSEN AS THE ANALYSIS FINDINGS AND EVENT ARE AN EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. SEE EXTERNAL SUPPORT REQUEST FORM 92379044. NO ESCALATION TO NCEP, CAPA, OR SCAR IS REQUIRED, COMPLAINTS ARE MONITORED FOR ESCALATION OF SYSTEMIC ISSUES THROUGH THE TRENDING PROCESS PER THE CIS PRODUCT INVESTIGATION WORK INSTRUCTION (WINDCHILL DOCUMENT # (B)(4)). IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, THE PRODUCT INVESTIGATION WILL BE REOPENED TO ADDRESS THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) SUDDENLY STOPPED WORKING AFTER 2 YEARS OF IMPLANTATION. UPON REMOVAL OF THE ENTIRE AUS SYSTEM, THE DOCTOR FOUND A LARGE TEAR IN THE BALLOON WHICH LED TO FLUID LOSS. A NEW AUS DEVICE WAS IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    MODEL: 72404131, LOT:12590001. MODEL: 72404127, LOT: 128891004.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 4.5 CM ARTIFICIAL URINARY SPHINCTER (AUS) DEVICE ABRUPTLY STOPPED WORKING 2 YEARS POST IMPLANT. THE PHYSICIAN IDENTIFIED A LARGE TEAR IN BALLOON RESULTING IN FLUID LOSS. ANOTHER DEVICE WAS IMPLANTED. THE PATIENTS STATUS IS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805472 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72400024 0152228013 00878953000626

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R