BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMON PANCREATIC STENT

    MDR report key: 2050899 · Received April 1, 2011

    Report

    Report Number
    3001845648-2011-00013
    Event Type
    Injury
    Date Received
    April 1, 2011
    Report Date
    March 7, 2011
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE INVOLVED IN THIS COMPLAINT IS AVAILABLE FOR EVALUATION BUT TO-DATE, IT HAS NOT BEEN REC'D AT COOK (B)(4) (THE MANUFACTURER). A DETAILED EVALUATION WILL BE CARRIED OUT WHEN THE DEVICE IS REC'D AT THE MANUFACTURER SITE. THE DEVICE INVOLVED IN THIS COMPLAINT IS AN (B)(4) (ZIMMON PANCREATIC STENT) DEVICE. 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. WE WERE INFORMED THAT THE DEVICE INVOLVED IN THIS COMPLAINT WAS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, THE DEVICE WAS NOT REC'D AT COOK (B)(4) TO-DATE. AS THE DEVICE WAS NOT REC'D, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. PRIOR TO DISTRIBUTION, ZIMMON PANCREATIC STENT ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE (B)(4) DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE REVIEWED AS THE LOT NUMBER COULD NOT BE PROVIDED. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED AS THE DEVICE HAS NOT YET BEEN REC'D FOR EVALUATION. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY OR PROGRESSION OF DISEASE STATE, COOK (B)(4) COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE, HOWEVER, CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    WHILE TRYING TO REMOVE A ZIMMON PANCREATIC STENT (5F 7CM SINGLE PIGTAIL STENT), THE STENT SEPARATED IN THE PT. THE PIGTAIL WAS CLEARLY OUTSIDE IN THE DUODENUM. THE TIP OF THE STENT WAS GRASPED WITH A SNARE AND THE STENT WAS PULLED. THE STENT FRACTURED SOMEWHERE CLOSE TO THE START OF THE PIGTAIL/RADIOOPAQUE MARKER. THE STENT DID NOT FRACTURE WHERE THE STENT WAS GRASPED WITH THE SNARE. ADDITIONAL PHYSICIANS WERE CALLED IN TO ASSIST; AFTER TIME THEY WERE ABLE TO REMOVE THE STENT WITH FORCEPS. THE PT IS FINE; HOWEVER, THE PT DID EXPERIENCE ADDITIONAL STRESS DUE TO THE EXTENDED PERIOD OF TIME REQUIRED IN THE PROCEDURE. THE PT WAS DISCHARGED IN GOOD CONDITION, FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMON PANCREATIC STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention