BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 9417699 · Received December 5, 2019

    Report

    Report Number
    2183959-2019-67928
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 14, 2019
    Report Date
    December 26, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS CONFIRMED A DEVICE MALFUNCTION. ANALYSIS SHOWED A PINHOLE LEAK IN THE OCCLUSIVE CUFF SHELL. THE CUFF DAMAGE IS CONSISTENT WITH A COMPRESSION SET AND FATIGUE. THE PRODUCT RECORD REVIEW INDICATED THAT THE REPORTED EVENTS DO NOT REPRESENT A NEW OR UNANTICIPATED EVENT. A FLUID LEAK WAS REPORTED. THE AMS 800 DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED. THE CUFF(S) BOTH MEASURED 4.0MM IN LENGTH. THERE WAS A LEAK IN ONE (1) OF THE OCCLUSIVE CUFF SHELLS THAT WAS CONSISTENT WITH COMPRESSION SET / FATIGUE. THE PUMP AND BALLOON WERE NOT FUNCTIONALLY TESTED DUE TO THE CUFF LEAK. THE FUNCTIONAL TEST FAILURES IDENTIFIED DURING PRODUCT ANALYSIS CONFIRM THE REPORTED FLUID LEAK ISSUES, AS THE PINHOLE IN THE CUFF IS THE PROBABLE CAUSE OF THE REPORTED ISSUES. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA OR SCAR IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A REPLACEMENT PROCEDURE OF HIS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO UNKNOWN REASONS. ALL COMPONENTS WERE EXPLANTED AND REPLACED. NO INFORMATION ABOUT THE PATIENT OUTCOME IS AVAILABLE AT THE MOMENT. ADDITIONAL INFORMATION WAS RECEIVED. DEVICE WAS EXPLANTED DUE TO FLUID LOSS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REPLACEMENT PROCEDURE OF HIS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO UNKNOWN REASONS. ALL COMPONENTS WERE EXPLANTED AND REPLACED. NO INFORMATION ABOUT THE PATIENT OUTCOME IS AVAILABLE AT THE MOMENT. ADDITIONAL INFORMATION WAS RECEIVED. DEVICE WAS EXPLANTED DUE TO FLUID LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211308 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R