BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKED SPRING TIP GUIDEWIRE

    MDR report key: 2721813 · Received August 30, 2012

    Report

    Report Number
    3007305485-2012-00061
    Event Type
    Malfunction
    Date Received
    August 30, 2012
    Report Date
    October 15, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K853274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 A SUPPLEMENTAL REPORT WILL BE SUBMITTED ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION OF THE INCIDENT. DEVICE EVAL ANTICIPATED YET NOT 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. THE DEVICE LOT NUMBER WAS NOT ORIGINALLY REPORTED BY THE END-USER FACILITY. THE DEVICE WAS RETURNED WITH THE PACKAGING THAT CONTAINED THE LOT NUMBER OF THE DEVICE. A DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW FOR LOT 1201204 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. ONE (1) USED DEVICE WAS RETURNED TO CONMED COMPLAINT HANDLING CENTER FOR INVESTIGATION. THE RETURNED DEVICE WAS EXAMINED IN THE LABORATORY. NO BENDING OF THE SPRING TIP OF THE GUIDEWIRE WAS OBSERVED DURING THE EXAMINATION. THE GUIDE WIRE / SPRING TIP SOLDER JOINT WAS ALSO ACCEPTABLE AND WITHOUT ANY OBVIOUS DAMAGE. HOWEVER, A SEVERE BEND IN THE SOLID METAL MANDREL GUIDE WIRE WAS OBSERVED, APPROXIMATELY 20 INCHES PROXIMAL TO THE SPRING TIP, WHICH WOULD RESULT IN MAKING THE DEVICE NONFUNCTIONAL. DHR/LHR REVIEW CONFIRMS THAT PRODUCTS WERE PRODUCED ACCORDING TO THE CONMED APPROVED PROCEDURES. IN-PROCESS & QUALITY CONTROL INSPECTION IS DONE ON THE PRODUCT AND THIS FAILURE MODE IS HIGHLY DETECTABLE. 100% HAND PULL & PROOF LOAD GUIDEWIRE TO SPRING TEST IS DONE FOR PROPER FUNCTION. FURTHERMORE, DAMAGED DEVICES ARE SCRAPPED DURING PRODUCTION. IMPROPER HANDLING OF THE DEVICE DURING SHIPPING FROM CONMED FACILITY TO CUSTOMER FACILITY COULD CAUSE THIS COMPLAINT. THE IFU, INFORMATION FOR USE, STATES, "REMOVE THE GUIDEWIRE FROM PACKAGING AND CAREFULLY INSPECT IT FOR ANY DAMAGE THAT MAY HAVE OCCURRED DURING TRANSIT OR HANDLING". THUS, ANY DAMAGED DEVICE SHOULD BE DETECTABLE PRIOR TO THE USE. DAMAGE DURING HANDLING COULD BE CAUSED BY THE USE OF EXCESSIVE FORCE BY THE END-USER. THE IFU WARNS THAT, "THE GUIDEWIRE SHOULD NOT BE ADVANCED IF RESISTANCE IS MET WITHOUT DETERMINING THE CAUSE AND TAKING REMEDIAL ACTION." THE QUESTION OF WHEN THIS DEVICE WAS PLACED IN SERVICE, AND, HOW FREQUENTLY THE DEVICE WAS UTILIZED REMAINS UNANSWERED. EXCEEDING THE LIFESPAN OF THE DEVICE AND AGGRESSIVE GUIDEWIRE ADVANCEMENT AND RETRACTION CAN RESULT IN DEVICE DAMAGE. POSSIBLE CAUSE FOR THIS COMPLAINT COULD BE DEVICE DAMAGE DURING SHIPPING AND/OR HANDLING, OR, EXCESSIVE FORCE UTILIZED BY THE END-USER. NO CONCLUSIVE MANUFACTURING RELATED CAUSES WERE DETERMINED DURING THE INVESTIGATION; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. THIS INCIDENT IS NOT RELATED TO THE SENTINEL EVENT AS REPORTED ON THE INITIAL FILING OF THIS MEDWATCH. THE SEVERE BEND OF THE SOLID MANDREL GUIDEWIRE APPROXIMATELY 20 INCHES PROXIMAL TO THE SPRING TIP WOULD HAVE RENDERED THIS DEVICE AS NONFUNCTIONAL. AFTER RECEIPT OF THIS DEVICE FROM THE END-USER FACILITY IT HAS BEEN DETERMINED THAT THIS WAS NOT A REPORTABLE EVENT. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "WE INSERTED THE WIRE & WITHDREW THE SCOPE AS WE ALWAYS HAVE DONE. WE USED 61 FR AE DILATOR. THE PATIENT FOUGHT A LITTLE, IT STUCK A LITTLE AT THE BITE BLOCK, WE LUBED IT, JEFF PROCEEDED TO APPLY PRESSURE, WE SAID SWALLOW, SHE FINALLY GAVE OR IT GAVE AND WE DILATED. WE DID LOOK BACK WITH THE SCOPE BECAUSE THERE WAS A LITTLE MORE HEME ON THE DILATOR, WE SAW THE WIRE HAD BENT WHEN WE PULLED IT OUT AND SHE FOUGHT THE STICKING, BUT THERE DIDN'T SEEM TO BE ANY DAMAGE TO THE PATIENT AND THE STRICTURE WAS STRETCHED". IT ALSO WAS REPORTED THAT THERE WAS NO INJURY TO PATIENT.

    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