BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LEUNG BILIARY STENT

    MDR report key: 2092575 · Received May 3, 2011

    Report

    Report Number
    3001845648-2011-00017
    Event Type
    Injury
    Date Received
    May 3, 2011
    Report Date
    April 5, 2011
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K896323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. AS THE LOT NUMBER WAS NOT PROVIDED; IT WAS THEREFORE NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBER IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE TO BE RETURNED FOR EVAL; THEREFORE THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. PRIOR TO DISTRIBUTION, ALL (B)(4) DEVICES ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR THE (B)(4) DEVICE INVOLVED IN THIS COMPLAINT REPORT COULD NOT BE REVIEWED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS UNK. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE COMPLAINT COULD NOT BE VERIFIED AS THE DEVICE WAS NOT RETURNED FOR EVAL. IT IS BELIEVED THAT THERE WERE NO ADVERSE EFFECTS ON THE PT AS A RESULT OF THIS OCCURRENCE. HOWEVER, COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    FOLLOWING PLACEMENT OF THE COTTON-LEUNG BILIARY STENT (B)(4), THE PT FAILED TO COME IN FOR REMOVAL OF THE DEVICE 6 WEEKS LATER. THE PT WAS THEN ADMITTED TO THE HOSPITAL ER AT AN UNK DATE WITH PAIN. SURGERY WAS PERFORMED AND IT WAS FOUND THAT THE STENT HAD PERFORATED THE SIGMOID COLON WALL. THE STENT HAD MIGRATED OUT OF THE COMMON BILE DUCT, WHICH IN TURN CAUSED THE PERFORATION. IT IS ASSUMED THE STENT WAS REMOVED, AND THE COLON WAS REPAIRED STATUS OF THE PT WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COTTON-LEUNG BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R