BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER

    MDR report key: 1950924 · Received December 14, 2010

    Report

    Report Number
    1220948-2010-00010
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    GBZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR THE EVALUATION. WE WERE NOT ABLE TO VERIFY THE FAILURE . THE ROOT CAUSE OF THE MALFUNCTION IS INCONCLUSIVE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND ALL MANUFACTURING AND QUALITY INSPECTIONS WERE COMPLETED IN ACCORDANCE TO THE MANUFACTURING INSTRUCTIONS. PLEASE NOTE THAT NO PT INJURIES HAPPENED.

    Description of Event or Problem · 1

    THE PT WAS SCHEDULED FOR A LAPAROSCOPIC CHOLECYSTECTOMY, POSSIBLE CHOLANGIOGRAM, WITH A PREOP OF ACUTE CHOLECYSTITIS/CHOLELITHIASIS. AN INCIDENTAL APPENDECTOMY WAS ALSO PERFORMED. NO IMMEDIATE POST OP COMPLICATIONS. THE MALFUNCTION WAS DETECTED AFTER THE CHOLANGIOGRAM WAS COMPLETED. THE SURGEON WAS UNABLE TO DEFLATE THE BALLOON TO REMOVE IT. THE SURGERY WAS CONVERTED TO AN OPEN CHOLECYSTECTOMY BY PERFORMING A LAPAROTOMY INCISION. EXTENDED RECOVERY DUE TO LARGER INCISION WAS REQUIRED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER REDDICK CHOLANGIOGRAM CATHETER GBZ LEMAITRE VASCULAR 2401-50 RST1900

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization