BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 12155516 · Received July 12, 2021

    Report

    Report Number
    2124215-2021-18990
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    June 3, 2021
    Report Date
    July 12, 2021
    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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE HOLE IDENTIFIED DURING ANALYSIS IS THE PROBABLE CAUSE FOR THE DEVICE TO BE EXPLANTED. THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE EXPLANT PROCEDURE. TECHNICAL ANALYSIS: THE PRODUCT WAS RETURNED FOR ANALYSIS TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. THE BALLOON COMPONENT WAS VISUALLY, MICROSCOPICALLY INSPECTED AND TESTED FOR LEAKS. A BIG TEAR ON THE TOP OF THE BALLOON SHELL AREA WAS OBSERVED. THE LEAK TEST FAILED DUE TO THE TEAR. UNDER THE MICROSCOPE, IT WAS NOTED THAT THERE IS LIGHT WEAR ON THE KRT (KINK RESISTANT TUBING). THE QWC (QUICK WINDOW CONNECTOR) WAS DAMAGED. THERE WAS SCALING ON THE BALLOON WHICH MOST LIKELY CAUSED A PINHOLE THAT EXTENDED INTO A TEAR AND THEN AN AVULSION. LABELING REVIEW: A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. DEVICE HISTORY RECORD: THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF CAUSED TRACED TO COMPONENT FAILURE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED WITH NO REPORTED ALLEGATION FROM THE FIELD, HOWEVER, THE DEVICE WAS EXPLANTED. A MALFUNCTION WAS IDENTIFIED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051791 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72400024 0145327010 00878953000626

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R