BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY CATHETER

    MDR report key: 2090283 · Received May 16, 2011

    Report

    Report Number
    2134265-2011-01710
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K023870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RECEIVED ONE VTCB/8.3 FLEXIMA REGULAR W/RO CATHETER DEVICE LOADED WITH FLEXIBLE STIFFENING CANNULA. RESIDUE WAS PRESENT IN THE DEVICE TO INDICATE USE. THE METAL CANNULA WAS RETURNED SEPARATE. FROM A VISUAL EVALUATION, THE FLEXIBLE CANNULA EXTRUSION WAS FOUND TO BE STRETCHED, FLATTENED AND BROKEN FROM CUSTOMER USAGE/ HANDLING DURING THE PROCEDURE. THE BROKEN PROXIMAL SECTION OF THE FLEX CANNULA WITH THE HUB WAS NOT RETURNED. WHEN ATTEMPTING TO REMOVE THE FLEXIBLE CANNULA FROM THE CATHETER, THE CATHETER EXTRUSION AT THE DISTAL END FURTHER BUCKLED/ ACCORDION. THE DISTAL END OF FLEX CANNULA EXTRUSION WAS STUCK INSIDE THE DISTAL TIP OF THE CATHETER AND EXCESSIVE FORCE HAD TO BE USED TO REMOVE THE FLEX CANNULA EXTRUSION FROM THE CATHETER. REMOVING THE CANNULA FROM THE CATHETER, THE CATHETER WAS FOUND TO BE INTACT BUT THE FLEX CANNULA EXTRUSION WAS STRETCHED, FLATTENED AND BROKEN. EXAMINING BOTH SECTIONS OF BROKEN FLEX CANNULA, IT WAS FOUND THAT THE FLEX CANNULA EXTRUSION WAS DRAWN OUT/ STRETCHED AND BROKE LIKELY DURING CUSTOMER ATTEMPT TO REMOVE THE CANNULA FROM THE CATHETER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS BILIARY DRAINAGE PROCEDURE THE SUTURE BROKE. THE PLASTIC STIFFENER STUCK INSIDE OF THE CATHETER AND DID NOT COME OUT AND THEN THE SUTURE BROKE AND CAME OFF. THE PHYSICIAN DID NOT HAVE A PROBLEM REMOVING THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS BILIARY DRAINAGE PROCEDURE THE SUTURE BROKE. THE PLASTIC STIFFENER STUCK INSIDE OF THE CATHETER AND DID NOT COME OUT AND THEN THE SUTURE BROKE AND CAME OFF. THE PHYSICIAN DID NOT HAVE A PROBLEM REMOVING THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M001272600 13380820

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR