BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 17239266 · Received June 30, 2023

    Report

    Report Number
    9680001-2023-00108
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    May 26, 2023
    Report Date
    June 30, 2023
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    EYA
    UDI-DI
    10816349011839
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS BEING FILED AS A MALFUNCTION TO ALIGN WITH THE DOCUMENTED EVENT RECORDED ON MDR REPORT # MW5118126. NOTE, THE INITIAL REPORTER ELECTED TO REMAIN CONFIDENTIAL; THEREFORE, MANY OF THE FIELDS WITHIN THIS REPORT HAVE BEEN LEFT BLANK. 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 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. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. 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

    PER MEDWATCH, IT WAS REPORTED THAT: SAFETY WIRE WAS REMOVED. INSPECTION OF GLIDEWIRE AT THE END OF THE CASE SHOWED 2 MILLIMETER(S) (MM) TIP OF GLIDEWIRE BROKE OFF. NOTE FROM DISTRIBUTOR RECEIVED (B)(6), 2023: WE WILL NOT BE ABLE TO SEND A FOLLOW UP ON THIS COMPLAINT SINCE INITIAL REPORTER AND HEALTH CARE FACILITY ARE UNKNOWN. THE DEVICE IS RETURNING; HOWEVER, IT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562335 ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL M0066802231 JRZ7140466 10816349011839

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown