BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE¿

    MDR report key: 22021724 · Received May 14, 2025

    Report

    Report Number
    9680001-2025-00007
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 14, 2025
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    EYA
    UDI-DI
    00816349011757
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DEVICE WAS DISCARDED; THEREFORE, NO PHYSICAL ANALYSIS OF THE DEVICE CAN BE PERFORMED. THE SUPPLIED THE IMAGE AND VIDEO PRESENTED A DUCTILE/TENSILE OVERLOAD FRACTURE OF THE POLYMER JACKET WITH AN UNKNOWN LENGTH OF MATERIAL REMOVAL, EXPOSING THE METALLIC CORE WIRE AT THE TIP. 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 TACTUALLY 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 DIRECTIONS FOR USE (DFU) PRECAUTIONS: - 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. AS NOTED IN THE DFU OPERATIONAL INSTRUCTIONS: TO ACTIVATE HYDROPHILIC COATING: - BEFORE REMOVING THE ZIPWIRE HYDROPHILIC GUIDEWIRE FROM THE PROTECTIVE HOOP (BY ITS DISTAL END), INJECT PHYSIOLOGICAL SALINE SOLUTION INTO THE HUB END OF THE HOLDER IN ORDER TO COMPLETELY WET THE SURFACE OF THE WIRE. 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 APPEARS THAT HANDLING DURING PREPARATION IMPACTED THE EVENT AS REPORTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION PROVIDED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED. NOTE: ALTHOUGH ANNEX G INSTRUCTIONS STATE THAT WITH STAND-ALONE DEVICES ANNEX G TERM SHOULD NOT BE USED, CODE 4755 WAS SELECTED DUE TO COMPONENT CODE (G) SHOWING UP ON THE MISSING DATA REPORT.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: AL ABRIR LA GUÍA EL UROLOGO SE DA CUENTA QUE LA PUNTA ESTÁ QUEBRADA Y SE QUEDA ATRAPADA EN EL DISPOSITIVO PLÁSTICO QUE TIENE PARA PROTEGER DICHA PUNTA / WHEN OPENING THE GUIDE, THE UROLOGIST REALIZES THAT THE TIP IS BROKEN AND GETS CAUGHT IN THE PLASTIC DEVICE THAT PROTECTS THE TIP. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? SE REEMPLAZA GUIA / GUIDE IS REPLACED. WHAT IS THE NEXT COURSE OF ACTION? SE CAMBIO LA GUIA Y SE FINALIZO EL PROCEDIMIENTO / THE GUIDE WAS CHANGED AND THE PROCEDURE WAS COMPLETED. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS DEVICE ACQUIRED FROM A DISTRIBUTOR? NO. ADDITIONAL INFORMATION FROM DISTRIBUTOR PROVIDED 29 APRIL 2025: WAS ISSUE PRESENT UPON OPENING PACKAGE? NO. PATIENT NAME-UNKNOWN. BIRTH DATE-UNKNOWN. WEIGHT-UNKNOWN. PATIENT GENDER IDENTITY: UNKNOWN. ADDITIONAL INFORMATION PROVIDED 8 MAY 2025: 1. PLEASE CONFIRM THERE WAS NO CONTACT WITH THE PATIENT. THERE WAS NO CONTACT WITH THE PATIENT. 2. PLEASE DESCRIBE THE PREPARATION STEPS. UNAVAILABLE. A. HOW DID THE END-USER ATTEMPT TO REMOVE THE GUIDEWIRE FROM THE DISPENSER HOOP? UNAVAILABLE. B. WAS ZIPWIRE HYDRATED PRIOR TO ATTEMPTING TO REMOVE THE GUIDEWIRE FROM THE DISPENSER HOOP? UNAVAILABLE. 3. WAS THERE ANY DAMAGE TO THE PACKAGING PRIOR TO OBSERVING THE REPORTED DAMAGE (PROTECTIVE HOOP, J-STRAIGHTENER)? UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230829 ZIPWIRE¿ UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL M00668020500 JRZ8647470 00816349011757

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown