BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 16683143 · Received April 5, 2023

    Report

    Report Number
    9680001-2023-00102
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 5, 2023
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    EYA
    UDI-DI
    08714729761716
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESPONSES TO THE END USERS QUESTIONS REGARDING THE GUIDEWIRE MATERIALS AND MRI COMPATIBILITY WERE PROVIDED. THE DEVICE WAS NOT RECEIVED FOR EVALUATION AT THE TIME OF THIS REPORT; THEREFORE, NO PHYSICAL ANALYSIS OF THE DEVICE CAN BE PERFORMED. LOT TRACEABILITY WAS NOT PROVIDED. THE LACK OF LOT TRACEABILITY PREVENTS PERFORMING A DEVICE HISTORY RECORDS REVIEW FOR ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES 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. AS NOTED IN THE DEVICE INSTRUCTIONS FOR USE (DFU) WARNINGS, · DO NOT MANIPULATE, ADVANCE AND/OR WITHDRAW THE ZIPWIRE HYDROPHILIC GUIDEWIRE THROUGH A METAL CANNULA OR NEEDLE. MANIPULATION, ADVANCEMENT, AND/OR WITHDRAWAL THROUGH A METAL DEVICE MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYMER JACKET REQUIRING RETRIEVAL. IF A NEEDLE IS USED FOR INITIAL PLACEMENT, A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THE ZIPWIRE HYDROPHILIC GUIDEWIRE. EXTREME CAUTION SHOULD BE OBSERVED WHEN USED WITH A ONE-WALL PUNCTURE NEEDLE. THE DFU PRECAUTIONS ALSO INDICATE, · 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. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION PROVIDED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: HELLO, PLEASE SEE COPY OF EMAIL FROM CUSTOMER BELOW - HOPE YOU CAN HELP ME TO FIND OUT WHAT THE ZIP WIRE IS MADE UP OF ? I BELIEVE IT IS CONSTRUCTED FROM A METALLIC CORE WITH OUTER POLYMER COATING. I JUST WANTED TO KNOW WHETHER ITS FLEXIBLE TIP CONTAINED ANY METAL AND IS THERE ANY CONTRAINDICATION FOR THE PATIENT TO UNDERGO MRI IN THE FUTURE AS A PART OF HIS FOLLOW UP TREATMENTS? UNFORTUNATELY, A TINY BIT OF OUTER COATING DISLODGED IN ONE OF OUR PATIENT'S KIDNEYS WHILE WE TRIED TO GET ACCESS TO A PROCEDURE CALLED PCNL. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: UNKNOWN . WHAT IS THE NEXT COURSE OF ACTION?: CUSTOMER WANTS TO KNOW MRI NEEDS TO OCCUR. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO . PATIENT COMPLICATIONS DEVICE ACQUIRED FROM A DISTRIBUTOR?: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242397 ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL M006630205B1 08714729761716

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other