BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATHWAY BALLOON EXPANDALB EURETERAL ACCESS SHE

    MDR report key: 3835842 · Received May 13, 2014

    Report

    Report Number
    3004672932-2014-00006
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ONSET MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K043254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    AS REPORTED: "PRODUCT INSERTED ITO LEFT URETER OF A (B)(6) FEMALE PATIENT WHO HAD A KIDNEY STONE. AFTER INSERTION AND AT APPROPRIATE LEVEL OF URETER IT WAS INFLATED GRADUALLY TO 25ATM AND HELD FOR 30 SECONDS AT WHICH POINT A POPPING SOUND WAS HEARD AND THE PRESSURE IN STERILE INFLATION DEVICE WAS AT ZERO ATM. INSERTION OF THE FLEXIBLE SCOPE REVEALED A PERFORATION OF THE URETER AT THE LEVEL JUST DISTAL TO THE PROXIMAL PART OF THE TIP OF THE PATHWAY ACCESS SHEATH. THE PATIENT HAD TO BE STENTED AFTER SEVERAL ATTEMPTS TO INSERT A GUIDEWIRE IN THE CORRECT LOCATION DUE TO THE TEAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285377 PATHWAY BALLOON EXPANDALB EURETERAL ACCESS SHE INTRODUCER DYB ONSET MEDICAL CORPORATION 255107 W035503

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention APPLIED URO WIRE| IK 1004 INFLATION SYRINGE