BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA¿

    MDR report key: 2212257 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03358
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FGE
    PMA / PMN Number
    K023870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED WITH A WHITE RESIDUE ON THE CATHETER'S PIGTAIL, AND THE FLEXIBLE STIFFENING CANNULA PRESENTS SEVERAL KINKS. FROM A VISUAL EVALUATION, IT WAS FOUND THAT THE CATHETER PRESENTED WHITE RESIDUE IN VARIOUS PARTS OF THE SHAFT. IT WAS NOTICED THAT THE WHITE MATERIAL FROM THE PACKAGING CARD WAS ADHERING TO THE COATED SECTIONS OF THE CATHETER. THE FLEXIBLE CANNULA WAS FOUND TO BE BENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS DESIGN. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2011-03507. IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS TREATMENT PROCEDURE MATERIAL WAS DISCOVERED ON THE DEVICE. THE PHYSICIAN WAS PERFORMING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM. WHEN NURSE OPENED THE PACKAGING SHE OBSERVED THAT SOME OF THE MATERIAL FROM THE PACKAGING ITSELF HAD GOTTEN CAUGHT ON THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT STATUS IS NOT AVAILABLE.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2011-03507. IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS TREATMENT PROCEDURE MATERIAL WAS DISCOVERED ON THE DEVICE. THE PHYSICIAN WAS PERFORMING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM. WHEN NURSE OPENED THE PACKAGING SHE OBSERVED THAT SOME OF THE MATERIAL FROM THE PACKAGING ITSELF HAD GOTTEN CAUGHT ON THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT STATUS IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA M001272600 0013828071

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR FLEXIMA DRAINAGE CATHETER