BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 17930748 · Received October 13, 2023

    Report

    Report Number
    9680001-2023-00119
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    August 29, 2023
    Report Date
    October 13, 2023
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    EYA
    UDI-DI
    10816349011822
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH REPORT IS BEING FILED BASED ON THE PRODUCT EVALUATION, WHICH REVEALED SKIVED/CUT DAMAGE TO THE POLYMER JACKET MATERIAL EXPOSING THE METALLIC CORE WIRE. AS RECEIVED, THE SPECIMEN CONSISTED OF ONE-1 EACH HYDRO GW STF STD S 150-035; RETURNED RELOADED INTO A DISPENSER ASSEMBLY AND DOUBLE-BAGGED WITHIN "ZIP-LOCK" STYLE POLY BIOHAZARD POUCHES. THE SPECIMEN PRESENTED AN OVERALL LENGTH OF 150 CM AND A FINISHED DIAMETER OF .03120" TO .03145". A GAGE BUSHING CERTIFIED TO BE .0350" PASSED OVER THE LENGTH OF THE SPECIMEN WITH NO MORE EFFORT THAN THE MASS OF THE BUSHING SLIDING DOWN THE WIRE SHAFT UNAIDED, EXCEPT BY GRAVITY TILL THE PROXIMAL ASPECT OF THE DAMAGE. NOTE ALL DIAMETER MEASUREMENTS WERE ACQUIRED WITH A NON-CONTACT, TOOLMAKERS SCOPE AFTER ALLOWING THE SPECIMEN DEVICE TO BECOME DRY AFTER HYDRATING THE SPECIMEN DEVICE WITH BLOOD-BANK SALINE. AFTER FLUSHING WITH BLOOD-BANK SALINE, THE SPECIMEN WAS SUBJECTED TO VISUAL AND TACTILE EXAMINATION. THE SPECIMEN COATING APPEARED VISUALLY AND TACTILELY CONSISTENT WHEN EXAMINED AT 1X - 18 INCHES, UNAIDED, WET. THE SPECIMEN PRESENTED APPROXIMATELY 12.8CM OF SKIVED/CUT DAMAGE TO THE POLYMER JACKET MATERIAL IN A PROXIMAL TO DISTAL ORIENTATION LOCATED 19.8CM TO 32CM FROM THE DISTAL TIP, EXPOSING THE METALLIC CORE WIRE. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARED VISUALLY AND DIMENSIONALLY CORRECT. THE DAMAGE PRESENTED BY THE SPECIMEN APPEARS CONSISTENT WITH MANIPULATION OF THE GUIDEWIRE AGAINST RESISTANCE. PLEASE NOTE, THERE IS NO MENTION OF THE SKIVED/CUT DAMAGE IN THE COMPLAINT NARRATIVE; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE EXACT TIMING OR CAUSE OF THE DAMAGE. AS NOTED IN THE DEVICE INSTRUCTIONS FOR USE (DFU) WARNINGS: MANIPULATE THE ZIPWIRE HYDROPHILIC GUIDEWIRE SLOWLY AND CAREFULLY IN THE URINARY SYSTEM WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY. EXCESSIVE MANIPULATION OF THE ZIPWIRE HYDROPHILIC GUIDEWIRE WITHOUT FLUOROSCOPIC CONFIRMATION MAY RESULT IN PERFORATION OR TRAUMA OF THE LININGS OR ASSOCIATED TISSUES, CHANNELS OR DUCTS. IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEM IMPROPER, STOP MANIPULATING THE WIRE AND/OR CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE ZIPWIRE HYDROPHILIC GUIDEWIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE URINARY SYSTEM. IF NECESSARY, REMOVE THE ZIPWIRE HYDROPHILIC GUIDEWIRE AND ANCILLARY DEVICE OR SCOPE AS A COMPLETE UNIT TO AVOID COMPLICATIONS. THE DFU PRECAUTIONS ALSO INDICATE : THE SURFACE OF THE ZIPWIRE HYDROPHILIC GUIDEWIRE IS NOT LUBRICIOUS UNLESS IT IS WET. BEFORE TAKING IT OUT OF ITS HOLDER AND INSERTING IT THROUGH A CATHETER, FILL THE HOLDER AND THE CATHETER WITH STERILE PHYSIOLOGICAL SALINE SOLUTION. THE ZIPWIRE HYDROPHILIC GUIDEWIRE SHOULD BE ADVANCED THROUGH THE SCOPE USING SHORT, DELIBERATE 2-3CM MOVEMENTS TO PREVENT INADVERTENT DAMAGE TO THE DEVICE OR PATIENT. DUE TO VARIATIONS IN CERTAIN CATHETER TIP DIAMETERS, ABRASION OF THE HYDROPHILIC COATING MAY OCCUR DURING MANIPULATION. IF ANY RESISTANCE IS FELT DURING INTRODUCTION OF THE CATHETER, IT IS ADVISABLE TO STOP USING SUCH CATHETERS. A REVIEW OF THE DEVICE HISTORY RECORDS OF THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. DURING MANUFACTURING THE PRODUCTION OPERATORS ARE INSTRUCTED TO 100% VISUALLY AND TACTILELY INSPECT FOR ANY OBVIOUS DEFECT, WHICH INCLUDES A TACTILE EXAMINATION OF THE ENTIRE LENGTH OF EACH WIRE. IN ADDITION, DURING PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED AND THE EVIDENCE PRESENTED, IT APPEARED THAT HANDLING AND/OR PROCEDURAL FACTORS HAVE CONTRIBUTED TO THE EVENT AS REPORTED.

    Description of Event or Problem · 0

    ECN EVENT DESCRIPTION: A RIGID URS WAS PERFORMED TO EXAMINE THE URETER FOR A URETERAL STONE. A 'SELECTIP' URETER CATHETER FROM BARD WAS USED FOR THIS PURPOSE, THROUGH WHICH THE BSC ZIPWIRE M0066802220 WAS PUSHED. CUSTOMERS THEN NOTICED THAT THE ZIPWIRE SHOWED A MATERIAL CHANGE. ACCORDING TO THE CUSTOMER, THE SURFACE OF THE ZIPWIRE IS NOT AS SMOOTH AS USUAL WITH THE PRODUCT. THE CUSTOMERS COMPLAIN ABOUT THE WIRE AND ASK FOR THE MATERIAL TO BE CHECKED. AN ERROR IN THE PRODUCT SELECTIP FROM THE EXTERNAL COMPANY BARD IS ALSO QUESTIONABLE FOR THE CUSTOMERS. A NEW ZIPWIRE M0066802220 WAS THEN USED FOR THE INVESTIGATION (ANOTHER OF THE SAME). ACCORDING TO THE CUSTOMER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? TAKE ANOTHER OF THE SAME PRODUCT. WHAT IS THE NEXT COURSE OF ACTION? CUSTOMER RESPONSE LETTER. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS? NO. PATIENT COMPLICATIONS DEVICE ACQUIRED FROM A DISTRIBUTOR? NO. ADDITIONAL INFORMATION RECEIVED 8 SEPTEMBER 2023: 1. WAS THERE VISIBLE DAMAGE TO THE DEVICE AND/OR ITS PACKAGING PRIOR TO USE? NO. 2. WAS THERE ANY DAMAGE NOTED TO THE GUIDEWIRE AFTER THE PROCEDURE? YES, THE SURFACE WAS UNEVEN/THE MATERIAL WAS PARTLY LOOSE. 3. ANY RESISTANCE FELT DURING INSERTION? CANNOT BE CLEARLY CLARIFIED BY THE USERS. IT IS UNCLEAR WHETHER THERE WAS RESISTANCE DURING THE INSERTION OR WITHDRAWAL. 4. WAS THERE AN ISSUE WITH LUBRICITY OF THE DEVICE? NO. 5. WAS THE ZIPWIRE FLUSHED DURING THE PROCEDURE? YES, THE ZIPWIRE AND COMPANION DEVICE WAS FLUSHED DURING THE PROCEDURE. 6. WHEN IS THE DEVICE EXPECTED TO BE RETURNED FOR EVALUATION? IT WILL BE RETURNED SEPTEMBER 4TH. ADDITIONAL INFORMATION RECEIVED 13 SEPTEMBER 2023: 1. DID THE CUSTOMER SPECIFY WHETHER OR NOT THE BLACK POLYMER JACKET MATERIAL WAS LOOSE OR MISSING? THE REP CONFIRMED THAT "NO, NOT MISSING, JUST LOOSE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552459 ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL M0066802221 JRZ8343466 10816349011822

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown