BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 1832969 · Received September 14, 2010

    Report

    Report Number
    2015691-2010-14053
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONLY THE CATHETER WAS RETURNED. CUSTOMER REPORT WAS CONFIRMED. THE BALLOON WAS FOUND TO BE RUPTURED IN THE CENTRAL AREA OF THE LATEX AND LATEX WAS MISSING. BOTH PROXIMAL AND DISTAL WINDINGS ARE IN GOOD CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE CATHETER WAS USED FOR GALLSTONE REMOVAL, BUT THE BALLOON RUPTURED DURING USE." THERE IS CONCERN THAT A BALLOON FRAGMENT REMAINED INSIDE THE PATIENT BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR 120803F UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1