BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 2802474 · Received October 18, 2012

    Report

    Report Number
    3001845648-2012-00059
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 24, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED CONFIRMED THE DEVICE INVOLVED IN THIS COMPLAINT TO BE A NPDS-5 DEVICE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, IT WAS NOT POSSIBLE TO CHECK IF ANY OF THE AFFECTED LOT REMAINED IN STOCK. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE INITIAL INFORMATION PROVIDED INDICATED: "ON (B)(6) 2012, THE PT'S ANATOMY WAS NORMAL AND NO RESISTANCE WAS MET WITH INSERTION OF THE WIRE GUIDE. THE USER INSERTED THE DRAINAGE CATHETER WITH SOME RESISTANCE AND PLACED IN THE PT. THE CATHETER LOOP WAS PLACED IN THE DESCENDING PORTION OF THE DUODENUM. ON (B)(6) 2012, THE DRAINAGE CATHETER BROKE IN THE DUODENUM DURING REMOVAL FLUOROSCOPICALLY. THE USER INSERTED A ENDOSCOPE AND TRIED TO REMOVE THE CATHETER USING A GRASPING FORCEPS BUT THE CATHETER BROKE AT WHERE THE FORCEPS GRASPED AGAIN. HE THEN GRASPED AND SUCCESSFULLY REMOVED THE CATHETER USING A SNARE. THE REMOVED STENT'S FLAP WAS HEAVILY BENT." FROM THE INFORMATION PROVIDED ABOVE IT CAN BE STATED THAT THE DRAINAGE CATHETER BROKE ON REMOVAL. A POSSIBLE CAUSE OF THE CATHETER BREAKING MAY BE ATTRIBUTED TO THE MANNER IN WHICH THE CATHETER WAS REMOVED. IF EXCESSIVE FORCE WAS USED WITH THE FORCEPS (ON THE REMOVAL OF THE DRAINAGE CATHETER) IT MAY HAVE CONTRIBUTED TO THE CATHETER BREAKING. HOWEVER, AS THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION, WE CANNOT CONCLUSIVELY DETERMINE IF THIS IS THE ROOT CAUSE OF THIS COMPLAINT AND THE CUSTOMER'S COMPLAINT REMAINS UNCONFIRMED. THE NPDS-5 INVOLVED IN THIS COMPLAINT CONSISTS OF THE FOLLOWING AFFECTED COMPONENT: RMN: (B)(4) (TUBING: (B)(4)). AS THE LOT NUMBER WAS NOT PROVIDED IT WAS NOT POSSIBLE TO CONDUCT A REVIEW OF THE ASSOCIATED MANUFACTURING RECORDS FOR THIS COMPONENT. PRIOR TO DISTRIBUTION ALL NPDS-5 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER OF THE NPDS-5 DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED; IT WAS NOT POSSIBLE TO CONDUCT A REVIEW OF THE MANUFACTURING RECORDS. THE NASAL PANCREATIC DRAINAGE SET IS INTENDED FOR ONE TIME USE. THIS DEVICE IS USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. (B)(4). THEREFORE THIS COMPLAINT FOR THIS SPECIFIC RPN REPRESENTS AN ISOLATED OCCURRENCE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT'S ANATOMY WAS NORMAL AND NO RESISTANCE WAS MET WITH INSERTION OF THE WIRE GUIDE. THE USER INSERTED THE DRAINAGE CATHETER WITH SOME RESISTANCE AND PLACED IN THE PT. THE CATHETER LOOP WAS PLACED IN THE DESCENDING PORTION OF THE DUODENUM. ON (B)(6), 2012, THE DRAINAGE CATHETER BROKE IN THE DUODENUM DURING REMOVAL FLUOROSCOPICALLY. THE USER INSERTED A ENDOSCOPE AND TRIED TO REMOVE THE CATHETER USING A GRASPING FORCEPS BUT THE CATHETER BROKE AT WHERE THE FORCEPS GRASPED AGAIN. HE THEN GRASPED AND SUCCESSFULLY REMOVED THE CATHETER USING A SNARE. THE REMOVED STENT'S FLAP WAS HEAVILY BENT. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK