BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKED SPRING TIP GUIDEWIRE

    MDR report key: 2825303 · Received November 8, 2012

    Report

    Report Number
    3007305485-2012-00109
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 25, 2012
    Report Date
    January 18, 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 3007305485-2011-00067. THE DEVICE HAS BEEN RETURNED TO CONMED CORPORATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN INITIATED. UPON COMPLETION OF THE QUALITY ENGINEERING EVALUATION A SUPPLEMENTAL REPORT WILL BE FILED. EVALUATION ANTICIPATED; NOT YET BEGUN.

    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 FOR LOT 1202204 HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. IN-PROCESS & QUALITY CONTROL (QC) INSPECTION IS DONE ON THE PRODUCT AND THIS FAILURE MODE IS HIGHLY DETECTABLE. DURING PRODUCTION 100% OF DEVICES ARE HAND PULL & PROOF LOAD TESTED FOR PROPER FUNCTION. FURTHERMORE, DAMAGED DEVICES ARE SCRAPPED DURING PRODUCTION. ONE (1) USED DEVICE WAS RETURNED TO CONMED COMPLAINT CENTER FOR COMPLAINT INVESTIGATION. THE RETURNED DEVICE WAS EXAMINED IN THE LABORATORY. THE PROXIMAL END OF THE SPRING TIP WAS OBSERVED TO BE BENT DURING THE EXAMINATION. IT IS HIGHLY UNLIKELY THAT THIS PRODUCT WAS SHIPPED TO THE END-USER IN THE CURRENT CONDITION. IMPROPER HANDLING OF THE DEVICE DURING SHIPPING FROM CONMED MANUFACTURING FACILITY TO THE END-USER FACILITY COULD CAUSE THIS COMPLAINT. THE IFU, INSTRUCTIONS FOR USE, SPECIFIES, "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". EXCESSIVE FORCE USED DURING THE DEVICE CLEANING PROCEDURE COULD ALSO 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 SHIPPING/CLEANING/HANDLING, OR, EXCESSIVE FORCE DURING PROCEDURAL USE BY THE END-USER. NO MANUFACTURING RELATED DEFECT WAS OBSERVED DURING THE INVESTIGATION; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED CORPORATION IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "TIP BENT IN HALF WITH LITTLE PRESSURE." IT ALSO WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARKED SPRING TIP GUIDEWIRE MARKED SPRING TIP GUIDEWIRE KNQ CONMED CORPORATION 1209244

    Patients

    Seq Age Sex Outcome Treatment
    1