BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 3163361 · Received June 11, 2013

    Report

    Report Number
    1625685-2013-00012
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 13, 2013
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    PMA / PMN Number
    K121849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE INVOLVED IN THE EVENT WAS EXAMINED AT THE CUSTOMER¿S LOCATION. THE FRAYED GUIDE WIRE WAS REMOVED FROM THE BIOHAZARD BAG IN WHICH IT WAS BEING KEPT. THE LENGTH OF THE COILED ¿UNFRAYED¿ GUIDEWIRE WAS EXAMINED. THE CUSTOMER CALLED THE GUIDE WIRE ¿FRAYED¿ DUE TO THE FACT THAT A SIGNIFICANTLY LONG PORTION OF THE COILED WIRE WAS NOT COILED AND NO LONGER WRAPPED AROUND THE INNER CORE. A GLOVED HAND WAS RUN ALONG THE ENTIRE LENGTH OF THE COILED ¿UNAFFECTED¿ GUIDEWIRE PORTION. NO ISSUES WERE FELT ALONG THAT LENGTH OF THE GUIDEWIRE. VISUAL INSPECTION SHOWED THE CORE EXPOSED FOR APPROXIMATELY 5 CM IN LENGTH. THE DISTAL END OF THE ¿NON-FRAYED¿ PORTION OF THE GUIDEWIRE HAD A GOOD WELD BEAD. NO DAMAGE WAS NOTED AT THAT LOCATION. DIMENSIONS WERE TAKEN ALONG THE GUIDEWIRE THAT WAS NOT FRAYED IN THREE LOCATIONS. A CALIPER WAS USED TO TAKE ALL MEASUREMENTS. THE DIAMETER AT ALL THREE LOCATIONS WAS CONSISTENT AT .037¿. THE WIRE THAT WAS UNCOILED HAD A DIAMETER OF .008¿. THE THREE LOCATIONS AT .037¿ DIAMETER WERE ALL WITHIN SPECIFICATION ACCORDING TO THE GUIDEWIRE DRAWING. (B)(6) MEDICAL CENTER WILL RETAIN THE GUIDEWIRE IN QUESTION FOR FUTURE REFERENCE. THERE WERE TWO DISTINCT PLASTICALLY DEFORMED BENDS IN THE CORE OF THE GUIDEWIRE. THE UNCOILED CORE ALSO HAD A BEND PORTION IN IT. IN CAREFUSION¿S DISCUSSION WITH THE CUSTOMER, THE GUIDEWIRE WAS PUT INTO A SHARPS CONTAINER IMMEDIATELY AFTER THE PROCEDURE. THE HOSPITAL STAFF PULLED THE ¿FRAYED¿ GUIDEWIRE OUT OF A SHARPS CONTAINER FOR FUTURE REFERENCE AND PLACED IT WITHIN A BIOHAZARD POLYBAG. IT IS NOT KNOWN WHEN OR WHAT CAUSED THESE BENDS IN THE GUIDEWIRE. PHOTOS WERE TAKEN OF THE ¿FRAYED¿ GUIDEWIRE. IN THESE PHOTOS, ONE CAN SEE A PORTION OF THE CORE THAT IS SPLIT OFF FROM THE MAIN BODY OF THE CORE SEVERAL CM FROM THE END. THIS SPLIT PORTION OF THE CORE WAS TANGLED WITH THE COIL WIRE. AT THIS TIME, IT IS UNKNOWN WHEN OR WHAT CAUSED THE GUIDEWIRE TO FRAY. SOME OF THE DAMAGE OF THE GUIDEWIRE MIGHT HAVE BEEN AN ARTIFACT OF PLACEMENT INTO THE SHARPS CONTAINER AND/OR REMOVAL FROM THE SHARPS CONTAINER. FROM A REVIEW OF THE FRAYED GUIDEWIRE, WE ARE NOT ABLE TO DETERMINE HOW MUCH OF THE GUIDEWIRE BROKE OFF INTO THE PATIENT. AT THIS TIME, IT IS ALSO NOT KNOWN HOW OR WHY THIS GUIDEWIRE FRAYED. IT IS ASSUMED THAT THE GUIDEWIRE WAS FREE OF DEFECT PRIOR TO PATIENT USE. IF THE TIP OF THE GUIDEWIRE WAS FRAYED, IT IS LIKELY THAT IT WOULD HAVE PRECLUDED ITS USE FOR THE PROCEDURE. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE J-WIRE GUIDEWIRE ASSEMBLY IS SUPPLIED BY AN EXTERNAL AND IS NOT ALTERED BY THE CAREFUSION MANUFACTURING FACILITY PRIOR TO PLACEMENT IN THE FINISHED TRAY. IN ADDITION, NO ISSUES WERE FOUND DURING REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INDICATED THAT COULD RESULT IN THE REPORTED CONDITION. THIS INCLUDES REVIEW OF RAW MATERIAL HISTORY FILES AND COMPONENTS USED DURING THE MANUFACTURE OF THE LOT INVOLVED. A REVIEW OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURES. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THIS ISSUE. THIS REPORT WILL BE ENTERED INTO THE SUPPLIER CORRECTIVE ACTION NOTIFICATION TRACKING SYSTEM PER PROCEDURE. AND THE SUPPLIER OF THE J-WIRE GUIDEWIRE ASSEMBLY (LAKE REGION MANUFACTURING) WILL BE NOTIFIED OF THIS REPORT IN AN EFFORT TO MINIMIZE ANY POTENTIAL IMPACT FROM THEIR MANUFACTURING PROCESSES. ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS REPORT IN AN EFFORT TO HEIGHTEN AWARENESS REGARDING THIS POTENTIAL DEFECT. THE MANUFACTURING PLANT WILL CONTINUE TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY FURTHER ACTIONS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED ON (B)(6) 2013, VIA A MEDWATCH REPORT COMPLETED BY THE FACILITY (VOLUNTARY REPORT NUMBER (B)(4)): DURING ULTRASOUND GUIDED PLACEMENT OF LEFT PLEURAL INDWELLING CATHETER, GUIDEWIRE WAS REMOVED AT THE END OF THE PROCEDURE. IT WAS NOTED TO BE UNRAVELED ON ONE END. POST-OP X-RAY SHOWED FOREIGN BODY WIRE ON LEFT ANTERIOR CHEST WALL. PATIENT ((B)(6) FEMALE) ELECTED NOT TO HAVE IT REMOVED, AS AN OPEN THORACOTOMY WOULD BE REQUIRED. ON (B)(6) 2013, THE CUSTOMER (B)(6) PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NOTHING NOTED OF THE GUIDEWIRE THAT WOULD INDICATE A DEFECT PRIOR TO USE. NO OTHER COMPONENTS IN THE TRAY WERE DAMAGED. THEY ARE NOT AWARE OF THE PHYSICIAN EXPERIENCING ANY DIFFICULTY WHILE INSERTING THE GUIDEWIRE. THE PHYSICIAN DID NOT HAVE TO DRAW BACK OR REPOSITION THE GUIDEWIRE AT ANY TIME DURING THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED AS EXPECTED. THE ONLY IMPACT ON THE PATIENT WAS THE RETAINED FOREIGN BODY. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE CUSTOMER INDICATED THAT THE SAMPLE WILL NOT BE RELEASED BUT CAN BE EVALUATED ON-SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264669 PLEURX PLEURAL CATHETER KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 50-7000B 0000509486

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR