BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKED SPRING TIP GUIDEWIRE

    MDR report key: 3051205 · Received April 10, 2013

    Report

    Report Number
    3007305485-2013-00039
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    April 30, 2013
    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

    THIS IS AN FDA REPORTABLE EVENT DUE TO A SENTINEL EVENT REPORTED ON MEDWATCH 3007305485-2013-00025. BOTH DEVICES HAVE BEEN DISCARDED BY THE END-USER AND ARE NOT BEING RETURNED TO CONMED CORPORATION FOR EVALUATION. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE SECOND DEVICE FROM THIS COMPLAINT IS REPORTED ON MEDWATCH 3007305485-2013-00038.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS THE MARKED SPRING TIP GUIDEWIRE, A 210CM 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, SAVARY, EDER PUESTOW, AND CELESTIN ESOPHAGEAL DILATOR SYSTEMS. A DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW WAS NOT ACCOMPLISHED FOR THE LOT NUMBER WAS NOT AVAILABLE. THE DEVICE WAS NOT RETURNED TO CONMED CORPORATION FOR EVALUATION. THE SPECIFIC FAILURE MODE AND ASSOCIATED ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED WITHOUT EXAMINATION OF THE ACTUAL DEVICE; THEREFORE THIS COMPLAINT IS CONSIDERED INCONCLUSIVE. POSSIBLE MANUFACTURING CAUSES OF THIS COMPLAINT COULD BE EXCESSIVE LOAD APPLIED TO THE GUIDE WIRE DURING THE PRODUCTION. IN-PROCESS & QUALITY CONTROL INSPECTION IS DONE ON THE PRODUCT AND THIS FAILURE MODE IS HIGHLY DETECTABLE. ONE HUNDRED PERCENT (100%) HAND PULL & PROOF LOAD, GUIDEWIRE TO SPRING TEST IS DONE TO ASSURE PROPER FUNCTIONING. FURTHERMORE, DAMAGED DEVICES ARE SCRAPPED DURING PRODUCTION. POSSIBLE CAUSES FOR THIS FAILURE MODE COULD BE DUE TO SHIPPING/HANDLING OR END USER RELATED ISSUES. IFU, INSTRUCTIONS FOR USE, SPECIFIES THAT, "REMOVE THE GUIDEWIRE FROM PACKAGING AND CAREFULLY INSPECT IT FOR ANY DAMAGE THAT MAY HAVE OCCURRED DURING TRANSIT OR HANDLING". THE IFU ALSO WARNS, "INSPECT THE FLEXIBLE SPRING TIP AND DISCARD THE WIRE IF THE TIP APPEARS TO BE BENT OR FATIGUED". ANY DAMAGED DEVICE SHOULD BE DETECTABLE PRIOR TO ITS USE. THE PROXIMAL END OF THE SPRING IS LESS FLEXIBLE THAN THE DISTAL END OF THE SPRING; THUS, EXCESS FORCE APPLIED ON THE DEVICE DURING GUIDEWIRE INSERTION PROCESS COULD CAUSE THE TIP TO BEND. THE IFU OF THE DEVICE INDICATES, "THE GUIDEWIRE SHOULD NOT BE ADVANCED IF RESISTANCE IS MET WITHOUT DETERMINING THE CAUSE AND TAKING REMEDIAL ACTION". ALSO, EXCESSIVE FORCE USED DURING THE DEVICE CLEANING PROCEDURE COULD CAUSE DAMAGE TO THE GUIDEWIRE. THE IFU SPECIFIES, "AVOID USING EXCESSIVE FORCE ON THE WIRE AND SPRING TIP WHILE CLEANING. DO NOT BEND TO TWIST THE SPRING TIP AS IT MAY CAUSE THE SOLDERED JOINTS TO DETERIORATE". POSSIBLE CAUSES FOR THIS COMPLAINT COULD BE DEVICE DAMAGE DURING CLEANING/HANDLING, OR, EXCESSIVE FORCE USED BY THE USER. NO MANUFACTURING RELATED DEFECT WAS OBSERVED DURING THE INVESTIGATION; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED CORPORATION IS CONSIDERING THIS COMPLAINTS CLOSED. THE SECOND DEVICE FROM THIS COMPLAINT IS REPORTED ON MEDWATCH 3007305485-2013-00038.

    Description of Event or Problem · 1

    IT WAS REPORTED, "GUIDEWIRE IS BENDING. THIS HAS HAPPENED 2 TIMES IN 2 SEPARATE PROCEDURES. THEY ARE KEEPING THE DEVICES IN THE ORIGINAL PACKAGES AND ARE MAKING SURE THAT THEY ARE NOT COILED. WANT TO MAKE SURE THAT THIS IS NOT GOING TO BECOME AN ONGOING ISSUE. WILL TRY AND SEE IF SHE CAN OBTAIN LOT INFO AND CALL BACK." IT ALSO WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149239 MARKED SPRING TIP GUIDEWIRE MARKED SPRING TIP GUIDEWIRE KNQ CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1