BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA CATHETER

    MDR report key: 6966804 · Received October 20, 2017

    Report

    Report Number
    2134265-2017-10312
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Report Date
    September 26, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: MOHAMMAD ALAA ABUSEDERA, "PERCUTANEOUS TREATMENT OF LARGE PYOGENIC LIVER ABSCESS", PUBLISHED (2014) 45, PAGES 109-115. (B)(4). THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT A CATHETER BECAME OCCLUDED. THE PATIENTS IN THIS STUDY RECEIVED EITHER PERCUTANEOUS DRAINAGE TREATMENT VIA NEEDLE ASPIRATION OR PERCUTANEOUS CATHETER DRAINAGE (CD) USING A MULTIPURPOSE FLEXIMA CATHETER OR ANOTHER NON BSC POLYURETHANE-BASED CATHETER TO TREAT THEIR PYOGENIC LIVER ABSCESS. AFTER DISCHARGE, ALL PATIENTS WERE FOLLOWED UP WITH PERIODIC CLINICAL AND US EXAMINATIONS TO ASSESS ANY RECURRENCE OF THE DISEASE AND TO MONITOR THE SIZE OF THE ABSCESS CAVITY. THE PATIENTS WERE EXAMINED WEEKLY DURING THE FIRST MONTH, MONTHLY FOR THE NEXT 3 MONTHS AND AT TWO MONTHLY INTERVALS THEREAFTER UNTIL COMPLETE RESOLUTION OF THE ABSCESS WAS ACHIEVED. IT WAS OBSERVED POST TREATMENT THAT CD WAS UNSUCCESSFUL IN SOME CASES AS IT WAS NOTED THAT THICK PUS AND DEBRIS OCCLUDED THE CATHETER WHICH RESULTED IN A CATHETER EXCHANGE IN SIZE FROM A 8 TO 12 FRENCH CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746710 FLEXIMA CATHETER TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK540

    Patients

    Seq Age Sex Outcome Treatment
    1