BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 9131874 · Received September 27, 2019

    Report

    Report Number
    2183959-2019-66430
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    September 12, 2019
    Report Date
    November 6, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953000763
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED PRODUCT CONSISTED OF AN AMS800 PRESSURE REGULATING BALLOON, OCCLUSIVE CUFF AND A CONTROL PUMP. THE AMS800 OCCLUSIVE CUFF WAS VISUALLY INSPECTED AND MICROSCOPICALLY EXAMINED. THE CUFF WAS MEASURED, AND THE DEVICE SIZE WAS CONSISTENT WITH THE REPORTED INFORMATION. FUNCTIONAL TESTS CONCLUDED THERE WAS A PINHOLE IN THE CUFF SHELL AT A FOLD CAUSING FLUID LOSS. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE AMS800 CONTROL PUMP WAS VISUALLY AND MICROSCOPICALLY EXAMINED. NO LEAKS WERE FOUND. THE PUMP WAS NOT FUNCTIONALLY TESTED DUE TO THE CONFIRMED CUFF LEAK. THE AMS800 PRESSURE REGULATING BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED. NO LEAKS WERE FOUND. FUNCTIONAL TESTS WERE NOT PERFORMED DUE TO THE CONFIRMED CUFF LEAK. CORRECTION TO G1, H2, H3, AND H6: UPDATED TO INCLUDE DEVICE ANALYSIS. BALLOON, MODEL- 72400024, LOT SN- 548464002, MFG DATE- 06/02/2008, EXP DATE- 05/22/2013, GTIN- (B)(4). PUMP: MODEL- 72400098, LOT SN- (B)(4), MFG DATE- 07/08/2008, EXP DATE- 07/03/2013, GTIN- (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO A PIERCED CUFF THE PATIENT HAD HIS ARTIFICIAL URINARY SPHINCTER (AUS) REMOVED AND REPLACED.

    Additional Manufacturer Narrative · 1

    BALLOON: MODEL- 72400024, LOT SN- (B)(4), MFG DATE- 06/02/2008, EXP DATE- 05/22/2013, GTIN- (B)(4). PUMP: MODEL- 72400098, LOT SN- (B)(4), MFG DATE- 07/08/2008, EXP DATE- 07/03/2013, GTIN- (B)(4). DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO A PIERCED CUFF THE PATIENT HAD HIS ARTIFICIAL URINARY SPHINCTER (AUS) REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923842 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72400165 397542010 00878953000763

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R