BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA¿ APDL

    MDR report key: 2801943 · Received October 23, 2012

    Report

    Report Number
    2134265-2012-06745
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE, DESCRIBE EVENT OR PROBLEM: UPDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE METAL CANNULA WAS STUCK TO THE CATHETER, THE CANNULA WAS SEVERELY KINKED IN TWO PLACES, THE KEY WAS NOT RETURNED, AND THE SUTURE WAS BROKEN. THE CANNULA WAS REMOVED SUCCESSFULLY WITH NO RESISTANCE ENCOUNTERED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE A CANNULA COULD NOT BE REMOVED FROM THE DEVICE. THE FLEXIMA DRAINAGE CATHETER WAS SELECTED AND WHEN THE DEVICE WAS IN PLACE, THE CANNULA COULD NOT BE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. HOWEVER, DEVICE ANALYSIS REVEALED A BROKEN SUTURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA¿ APDL TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001271330 15107556

    Patients

    Seq Age Sex Outcome Treatment
    1