BEUDAMED
    FDA Adverse Event Other Summary report: N

    REDDICK CHOLANGIOGRAM CATHETER

    MDR report key: 2115416 · Received November 17, 2008

    Report

    Report Number
    1220948-2008-00010
    Event Type
    Other
    Date Received
    November 17, 2008
    Date of Event
    June 2, 2008
    Report Date
    October 28, 2008
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    GBZ
    PMA / PMN Number
    K030041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND THE REPORTED COMPLAINT MADE BY THE HOSPITAL COULD NOT BE CONFIRMED. DURING A RECENT AUDIT OF OUR INTERNAL COMPLAINT FILES IT WAS FOUND THAT TWO SEPARATE INSTANCES OF THE SAME PRODUCT COMPLAINT FROM (B)(6) WERE REPORTED TO THE FDA AT THE SAME TIME. INITIALLY, THEY WERE INTERNALLY FILED TOGETHER, BUT DURING A RECENT REVIEW OF THE FILES, THE HOSPITAL WAS ABLE TO CONFIRM THAT THEY WERE BOTH SEPARATE COMPLAINTS. RST1292 WAS REPORTED INITIALLY, DEVICE EVALUATIONS WERE PERFORMED AND A MEDWATCH FILE WAS COMPLETED (REF. 1220948-2008-00005). WE HAVE OPENED AN INTERNAL FILE FOR RST1251 AND THIS IS THE INITIAL AND FINAL REPORT THAT IS BEING SUBMITTED. THE HOSPITAL REP (B)(6) (RN) AT (B)(6) WAS CONTACTED ABOUT THE EXACT SAME COMPLAINT BUT DIFFERENT LOT NUMBER (REF. 1220948-2008-00005) SHE STATED THAT THE PHYSICIAN WAS UNABLE TO INSERT THE CATHETER INTO THE INTRODUCER DURING PROCEDURE. HE WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER DEVICE. SINCE THIS DEVICE WAS NOT RETURNED FOR EVALUATION, WE CANNOT DETERMINE THE ROOT CAUSE, BUT IT IS SIMILAR TO THE OTHER COMPLAINT. WE FEEL THAT WHEN ASSESSING THE COMPLAINT RISK, WE DO NOT FEEL THIS IS A REPORTABLE MDR AS IT APPEARS TO BE A USER INCONVENIENCE.

    Description of Event or Problem · 1

    TITLE: REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER. EVENT DESC: THE REDDICK CATHETER WOULD NOT FIT DOWN THE INTRODUCER WITHOUT BREAKING THE BALLOON. OPEN ANOTHER CATHETER WITH LOT # RST1251 AND THE BALLOON BROKE ON THE CATHETER AGAIN WHEN IT WAS ADVANCED DOWN THE INTRODUCER. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION: THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDDICK CHOLANGIOGRAM CATHETER REDDICK GBZ LEMAITRE VASCULAR 2401-52 RST1251

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR