BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA CATHETER

    MDR report key: 2001182 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00539
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHEMO EMBOLIZATION TREATMENT PROCEDURE, A CATHETER FRACTURE OCCURRED. THE PATIENT HAD A 6.3 FLEXIMA FIRM DRAINAGE CATHETER PLACED WITHOUT COMPLICATION IN THE SPLENIC CONDUIT TO TREAT A SPLENIC ABSCESS. THE DEVICE WAS LEFT IN PLACE FOR 9 DAYS, AND THERE WERE NO ISSUES WITH ITS OPERATION. ON THE 9TH DAY, THE PHYSICIAN PROCEEDED TO USE THE PREVIOUSLY PLACED CATHETER FOR A CHEMO EMBOLIZATION PROCEDURE. THE ABSCESS WAS FLUSHED WITH ABSOLUTE ALCOHOL. PER THE PHYSICIAN, THE PORTION OF THE CATHETER THAT WAS IN CONTACT WITH THE ALCOHOL "LOST ITS WAY AND BECAME SOFT". USING A GUIDE, AN ATTEMPT WAS MADE TO WITHDRAW THE DEFORMED CATHETER. RESISTANCE WAS ENCOUNTERED AND THE CATHETER FRACTURED INSIDE THE PATIENT. IT WAS REPORTED THAT ABOUT 7 INCHES OF THE CATHETER BROKE OFF INSIDE THE PATIENT, AT THE PORTION OF THE CATHETER WHERE THE DRAIN HOLES BEGIN. THE FRACTURED SEGMENT REMAINS IN THE SPLENIC ABSCESS. THE PATIENT WAS OBSERVED AND TREATED WITH 9 DAYS OF ORAL LEVOFLOXICIN. PER THE PHYSICIAN, IF THE PATIENT CONTINUES TO COLLECT SPLENIC ABSCESS FLUID, THEN THEY WILL PERFORM SURGERY TO REMOVE THE CATHETER SEGMENT. THE PATIENT'S CONDITION IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA CATHETER TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - SPENCER M001271310 13181520

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R