BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKED SPRING TIP GUIDEWIRE

    MDR report key: 2417026 · Received January 16, 2012

    Report

    Report Number
    3007305485-2012-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2012
    Date of Event
    December 16, 2011
    Report Date
    March 16, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K853274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING RETAINED BY THE END-USER FACILITY RISK MANAGEMENT DEPARTMENT. CONMED CORPORATION IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ON COMPLATION OF THE QUALITY ENGINEERING INVESTIGATION OF THE INCIDENT. DEVICE NOT RETURNED TO CONMED CORP.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS THE MARKED SPRING TIP GUIDEWIRE, A 210 CM LONG SOLID METAL MANDREL WITH A FLEXIBLE, VARIABLE THREAD, SPRING ATTACHED TO THE PROXIMAL TIP. THE MARKED SPRING TIP GUIDEWIRE IS A REUSABLE INSTRUMENT TO BE USED IN CONJUNCTION WITH AMERICAN DILATORS AND IS COMPATIBLE WITH KEY MED, (B)(6) AND CELESTIN ESOPHAGEAL DILATOR SYSTEMS. THIS WAS ORIGINALLY REPORTED AS A REPORTABLE EVENT DUE TO A SENTINEL EVENT REPORTED ON MEDWATCH 3007305485-2011-00067. THE FAILURE MODE FROM THE SENTINEL EVENT WAS THE PROXIMAL END OF THE SPRING TIP WAS BENT (NOT BROKEN AS INITIALLY REPORTED BY THE END-USER). THE FAILURE MODE OF THIS INCIDENT IS NOT RELATED TO THE SENTINEL EVENT FAILURE MODE. THIS EVENT DID NOT RESULT IN ANY PATIENT INJURY OR SURGICAL DELAY. THIS WAS ERRONEOUSLY REPORTED UNDER THE ABOVE SENTINEL EVENT. CONMED CORPORATION DOES NOT CONSIDER THIS TO BE A REPORTABLE EVENT. NOT RETURNED TO CONMED CORP.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS THE MARKED SPRING TIP GUIDEWIRE, A 210 CM LONG SOLID METAL MANDREL WITH A FLEXIBLE, VARIABLE THREAD, SPRING ATTACHED TO THE PROXIMAL TIP. THE MARKED SPRING TIP GUIDEWIRE IS A REUSABLE INSTRUMENT TO BE USED IN CONJUNCTION WITH AMERICAN DILATORS AND IS COMPATIBLE WITH KEY MED, (B)(6) AND CELESTIN ESOPHAGEAL DILATOR SYSTEMS. A DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW WAS NOT CONDUCTED AS THE LOT NUMBER WAS NOT MADE AVAILABLE. THE LOT NUMBER WAS NOT PROVIDED SO THE AGE OF THE DEVICE IS UNKNOWN. (B)(4). NO PRODUCT WAS RETURNED FOR EXAMINATION OR CONFIRMATION OF DEFECT OR CONFIRMATION OF CONMED PRODUCT. HOWEVER, PICTURES OF THE COMPLAINT DEVICE WERE SENT TO CONMED COMPLAINT HANDLING CENTER FOR CONFIRMATION. THE REVIEW OF THE PICTURES CONFIRMED THE DETACHMENT OF THE SPRING TIP FROM THE STAINLESS STEEL GUIDEWIRE. THE SPRING TIP DOES NOT APPEAR TO BE FRACTURED BUT HAS BECOME UNSOLDERED FROM THE GUIDEWIRE. A POSSIBLE MANUFACTURING CAUSE RELATED TO IMPROPER FLUX APPLICATION AND SOLDERING IS UNLIKELY AS IMPROPER SOLDERING OF THE PARTS COULD RESULT IN DETACHMENT OF THE TIP FROM THE GUIDEWIRE AND THUS A NON FUNCTIONAL DEVICE. EVIDENCE OF SOLDERING ON THE DISTAL END OF THE GUIDEWIRE WAS OBSERVED DURING THE EXAMINATION OF THE PHOTOGRAPHS. IN PROCESS INSPECTION IS DONE ON THE DEVICES AND DETECTABILITY OF THIS FAILURE MODE IS HIGH. A 100% PROOF LOADING AND HAND PULL TEST IS DONE ON DEVICES PRODUCED DURING MANUFACTURING TO AVOID SPRING DETACHMENT. ALL GUIDEWIRES PASS THE HAND PULL TEST OR THEY ARE DISCARDED DURING THE MANUFACTURING PROCESS. FURTHERMORE, SAMPLE DEVICES ARE INSPECTED FOR CORRECT DIMENSIONS, SOLDERING AND BUFFING OF THE GUIDEWIRE. EXCEEDING THE LIFESPAN OF THE DEVICE AND GUIDEWIRE ABUSE AS IN AGGRESSIVE GUIDEWIRE ADVANCEMENT AND RETRACTION CAN RESULT IN DEVICE DAMAGE. THE IFU, INFORMATION FOR USE, WARNS THAT, "THE GUIDEWIRE SHOULD NOT BE ADVANCED IF RESISTANCE IS MET WITHOUT DETERMINING THE CAUSE AND TAKING REMEDIAL ACTION." OUR INVESTIGATION REVEALED THAT THE END-USER UTILIZED THE PROPER, MANUFACTURER RECOMMENDED CLEANING SOLUTION TO CLEAN AND DISINFECT THE DEVICE. THE CUSTOMER HAS REPORTED THAT THE GUIDEWIRE IS MECHANICALLY CLEANED BY A TECH, PLACED IN CIDEX, RINSED IN A CUSTOM ULTRASONIC MACHINE (USED TO CLEAN SCOPES). ROOT CAUSE OF THE ISSUE IS SPECULATIVE AND CANNOT BE DETERMINED WITHOUT ACTUAL EXAMINATION OF THE SUSPECT DEVICE. THE IFU FURTHER WARNS, "SINCE THE MARKED GUIDEWIRE IS A REUSABLE DEVICE THAT IS SUBJECTED TO VARIED USE AND CLEANING ENVIRONMENTS, THE LIFE SPAN OF THE PRODUCT CANNOT BE GUARANTEED. IN PARTICULAR, LESS THAN 1% OF THE SPRING TIPS HAVE BEEN REPORTED TO HAVE BECOME DISLODGED DURING USE OR CLEANING. DISLODGEMENT OF THE SPRING TIP DURING USE MAY REQUIRE ENDOSCOPIC REMOVAL OF THE SPRING TIP. FAILURE TO REMOVE THE TIP MAY LEAD TO THE PERFORATION OF THE ESOPHAGUS, STOMACH OR BOWEL AND THE CONSEQUENCES CUSTOMARILY ASSOCIATED THEREWITH, INCLUDING DEATH." THE IFU CONTINUES AND INSTRUCTS TO, "CAREFULLY INSPECT THE GUIDEWIRE AFTER EACH USE. INSPECT THE FLEXIBLE SPRING TIP AND DISCARD THE WIRE IF THE TIP APPEARS TO BE BENT OR FATIGUED. ALSO INSPECT THE SOLDERED JOINTS AND DISCARD THE WIRE IF THE SOLDERED JOINTS APPEAR DISCOLORED, LOOSE OR CRACKED." NO ROOT CAUSES CAN BE CONCLUSIVELY CONFIRMED WITHOUT EXAMINATION OF THE ACTUAL DEVICE. NO CONCLUSIVE MANUFACTURING RELATED CAUSES WERE DETERMINED DURING THE INVESTIGATION; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. NOT RETURNED TO CONMED CORP.

    Description of Event or Problem · 1

    IT WAS REPORTED, "TIP TO GUIDEWIRE BROKE OFF AFTER INSERTION OF SAVORY DILATOR. TIP WAS RETRIEVED BY PHYSICIAN WITH SNARE. NO INJURY TO PATIENT OCCURRED. OCCURRED ON (B)(6) 2011".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARKED SPRING TIP GUIDEWIRE MARKED SPRING TIP GUIDEWIRE KNQ CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1