BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 12660960 · Received October 19, 2021

    Report

    Report Number
    2126666-2021-00045
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 24, 2021
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    EYA
    UDI-DI
    08714729755326
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: AS RECEIVED, THE SPECIMEN CONSISTED OF ONE-1 EACH HYDRO GW STF STD S 150-035; RETURNED PARTIALLY RELOADED INTO THE DISPENSER ASSEMBLY AND DOUBLE-BAGGED WITHIN "ZIP-LOCK" STYLE POLY POUCHES. THE RECOVERED MATERIAL WAS NOT RETURNED WITH THE SPECIMEN DEVICE. THE SPECIMEN PRESENTED CUT/SKIVE DAMAGE TO THE POLYMER JACKET 43.20CM FROM THE DISTAL TIP WITH THE POLYMER JACKET MATERIAL DISPLACED DISTALLY OVER ITSELF 24.6 TO 31.3CM FROM THE DISTAL TIP, EXPOSING THE METALLIC CORE WIRE 31.3 TO 43.2CM FROM THE DISTAL TIP. THE DISPLACED MATERIAL RESULTED IN OVERSIZED DIAMETER TO .05565" 24.6 TO 31.3CM FROM THE DISTAL TIP. THE SPECIMEN ALSO PRESENTED A LARGE RADIUS BEND OVER THE DISTAL 7.00CM. 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. AS INDICATED IN THE DEVICE INSTRUCTIONS FOR USE, 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." 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 CLINICAL AND OR PROCEDURAL FACTORS HAVE CONTRIBUTED TO THE EVENT AS REPORTED. IF ANY FURTHER INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: IT WAS REPORTED THAT: WE HAD A STIFF ZIPWIRE THAT BROKE WHILE BEING USED IN A PATIENT. THEY WERE ABLE TO GET THE BROKEN PIECE OUT AND USE ANOTHER ONE BUT WANTED TO REPORT IT TO SOMEONE. I DO HAVE THE ITEM IN MY OFFICE IN A BIOHAZARD BAG.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION AT THE TIME OF THIS REPORT; THEREFORE, NO PHYSICAL ANALYSIS OF THE DEVICE CAN BE PERFORMED. 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 TACTICALLY 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. IF ANY FURTHER INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: IT WAS REPORTED THAT: WE HAD A STIFF ZIPWIRE THAT BROKE WHILE BEING USED IN A PATIENT. THEY WERE ABLE TO GET THE BROKEN PIECE OUT AND USE ANOTHER ONE BUT WANTED TO REPORT IT TO SOMEONE. I DO HAVE THE ITEM IN MY OFFICE IN A BIOHAZARD BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557426 ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL M006630222B1 6378797 08714729755326

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other