BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARACHUTE STONE RETRIEVAL DEVICE

    MDR report key: 352443 · Received September 21, 2001

    Report

    Report Number
    6000043-2001-00110
    Event Type
    Injury
    Date Received
    September 21, 2001
    Date of Event
    August 18, 2001
    Report Date
    August 21, 2001
    Manufacturer
    MICROVASIVE UROLOGY, A DIVISON OF BOSTON SCIENTIFIC CORP.
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETERAL STONE RETRIEVAL PROCEDURE, A PARACHUTE BASKET WOULD NOT CLOSE, AND INJURED THE URETER AS IT WAS PULLED OUT. A SECOND PARACHUTE BASKET WAS DEPLOYED AND THE SAME PROBLEM OCCURRED. A SEGURA BASKET WAS THEN DEPLOYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS OK AFTER THE PROCEDURE, WITH EDEMA OF THE URETER. IN THE PARACHUTE BASKET DIRECTIONS FOR USE, POTENTIAL COMPLICATIONS INCLUDE: URETERAL PERFORATION, URETERAL EVULSION AND EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43116 PARACHUTE STONE RETRIEVAL DEVICE STONE RETRIEVAL BASKETS FFL MICROVASIVE UROLOGY, A DIVISON OF BOSTON SCIENTIFIC CORP. NA 3506317

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization