BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKED SPRING TIP GUIDEWIRE

    MDR report key: 3832446 · Received May 27, 2014

    Report

    Report Number
    3007305485-2014-00059
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 1, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K853274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION IS ANTICIPATED; HOWEVER, HAS NOT COMMENCED TO DATE. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ON 09-MAY-2014, CONMED RECEIVED ONE (1) USED/DAMAGED MARKED SPRING TIP GUIDEWIRE FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND VISIBLE SOLDER REMNANT ON THE WIRE AND DOWN THE GUIDEWIRE END, WHICH INDICATES A SATISFACTORY SOLDER ATTACHMENT. THE SPRING TIP WAS ALSO RETURNED SEPARATELY TO CONMED ON 26-JUN-2014 FOR EVALUATION AFTER IT WAS RETRIEVED FROM THE PATIENT DURING THE SECOND SURGERY ON (B)(6) 2014 BY COLONOSCOPY. VISUAL INSPECTION OF THE RETURNED SPRING TIP FOUND THE TIP WAS SLIGHTLY BENT AT THE PROXIMAL END OF THE COMPONENT. IN THIS INSTANCE, THE EXACT CAUSE OF THE SPRING TIP BREAKAGE WAS UNABLE TO BE DETERMINED. HOWEVER, EVALUATION OF SIMILAR COMPLAINTS REVEALED THAT THE BENT/DAMAGED SPRING TIP CAN OCCUR IF EXCESSIVE FORCE WAS USED DURING THE PROCEDURE AND/OR DURING CLEANING OF THE GUIDEWIRE AND THE SPRING TIP BETWEEN EACH USE. IN ADDITION, INFORMATION RECEIVED FROM THE END-USER REGARDING THEIR CLEANING METHODS FOR THE DEVICE INDICATED THAT THE FACILITY PRE-CLEANS THE GUIDEWIRE IN ASEPTIZYME, AND THEN PROCESS IN THE STERIS SYSTEM 1E. THE ACTIVE INGREDIENT OF THE LIQUID CHEMICAL STERILANT USED IN THE STERIS SYSTEM 1E IS PERACETIC ACID. THIS CLEANING METHOD SUGGESTED THAT THE USER FACILITY FAILED TO PROPERLY FOLLOW THE CLEANING INSTRUCTIONS AS INDICATED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU). CLEANING THE SPRING TIP GUIDEWIRE WITH HARSH CHEMICALS SUCH AS PERACETIC ACID CAN RESULT IN WEAKENED SOLDER JOINT, WHICH COULD CAUSE THE SPRING TIP DETACHMENT AND MAY REDUCE THE LIFE OF THE GUIDEWIRE. ADDITIONALLY, THIS IS A REUSABLE DEVICE AND THE NUMBER OF SURGICAL USES AND THE CLEANING/STERILIZATION CYCLES WAS NOT PROVIDED. TO PREVENT THE PROBLEM FROM RECURRING, AN EDUCATION LETTER WILL BE SENT TO THE USER FACILITY TO REITERATE THE IMPORTANCE OF FOLLOWING THE IFU. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. ADDITIONALLY, A 2-YEAR REVIEW OF THE DEVICE COMPLAINT HISTORY SHOWS OTHER THAN THIS REPORTED INCIDENT, THERE HAVE BEEN NO ADVERSE EVENTS RECEIVED RELATED TO THIS PRODUCT AND THE REPORTED BREAKAGE. THE MARKED SPRING TIP GUIDEWIRE IS A SOLID METAL MANDREL WITH A FLEXIBLE VARIABLE THREAD SPRING ATTACHED TO IT. THE MARKED SPRING TIP GUIDEWIRE IS TO BE USED WITH AMERICAN DILATORS AND IS COMPATIBLE WITH KEY MED, SAVARY, EDER PUESTOW, AND CELESTIN ESOPHAGEAL DILATATION SYSTEMS. TO REDUCE THE RISK OF THE SPRING TIP BREAKAGE AND THE PATIENT INJURY, THE IFU PROVIDES THE FOLLOWING PRECAUTIONS AND WARNINGS: PRECAUTIONS: RADIOLOGICAL MONITORING OF THE GUIDEWIRE IN THE GASTRIC CAVITY IS RECOMMENDED WHEN INTRODUCING AND REMOVING DILATORS. WARNINGS: THE GUIDEWIRE SHOULD NOT BE ADVANCED IF RESISTANCE IS MET WITHOUT DETERMINING THE CAUSE AND TAKING REMEDIAL ACTION. 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 REUSE 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. 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. INSTRUCTION FOR CLEANING: THE GUIDEWIRE SHOULD BE CLEANSED BY A THOROUGH MECHANICAL SCRUBBING USING SOAP AND WATER. AVOID USING EXCESSIVE FORCE ON THE WIRE AND SPRING TIP WHILE CLEANING. DO NOT BEND OR TWIST THE SPRING TIP AS IT MAY CAUSE THE SOLDERED JOINTS TO DETERIORATE. INSTRUCTIONS FOR DISINFECTION ALSO CAN BE FOUND ON THE DEVICE IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2014, " DURING USE THE TIP BROKE OFF INSIDE PATIENT AND WAS NOT RETRIEVED. THE CLINICIAN STATED THAT THE TIP WILL PASS THROUGH THE PATIENT. PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION OR ADDITIONAL HOSPITAL STAY. " ADDITIONAL INFORMATION RECEIVED FROM THE END USER STATES THAT THE CLINICAL PROCEDURE BEING PERFORMED WAS A EGD ( UPPER ENDOSCOPY), WITH DILATATION USING A SAVORY DILATOR. (B)(4) 2014 - IT WAS LEARNED THAT THE PATIENT UNDERWENT AN ADDITIONAL COLONOSCOPY TO RETRIEVE THE BROKEN TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311299 MARKED SPRING TIP GUIDEWIRE MARKED SPRING TIP GUIDEWIRE KNQ CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention