BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 16942477 · Received May 16, 2023

    Report

    Report Number
    9680001-2023-00104
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 16, 2023
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    EYA
    UDI-DI
    10816349011761
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DEVICE WAS USED FOR AN INSERTION OF A VENOUS ACCESS PORT. PLEASE NOTE THAT THIS MODEL OF ZIPWIRE HYDROPHILIC GUIDEWIRE IS INTENDED FOR UROLOGICAL USE AND IS LABELED AS SUCH. ATTEMPTS WERE MADE TO GATHER ADDITIONAL DETAILS REGARDING THIS EVENT; HOWEVER, IT WAS REPORTED THAT FURTHER DETAIL, INCLUDING THE PATIENT OUTCOME, WAS NOT AVAILABLE. IT WAS REPORTED THAT THE DEVICE WAS DISPOSED; 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 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. BASED ON THE INFORMATION PROVIDED, IT APPEARED THAT CLINICAL AND/OR PROCEDURAL FACTORS MAY HAVE IMPACTED ON 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: THE MATERIALS MANAGER SAID THAT THE ZIPWIRE CAME APART AND SOME SMALL FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE DETAILS AND LOCATION WERE UNCLEAR. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: UNKNOWN. WHAT IS THE NEXT COURSE OF ACTION?: JUST TO DOCUMENT THE SITUATION THE BEST I CAN PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: UNRETRIEVED DEVICE FRAGMENTS (UDF). IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: UNKNOWN. MEDICAL OR SURGICAL INTERVENTIONS: UNKNOWN. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN. PATIENT OUTCOME: UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: WHAT WAS THE NAME OF THE PROCEDURE(S) PERFORMED? INSERTION OF VENOUS ACCESS PORT. DID THIS EVENT OCCUR DURING INSERTION, ADVANCEMENT OR WITHDRAWAL? DURING PROCEDURE. (B)(6) 2023, DISTRIBUTOR SENT NOTIFICATION OF AN UPDATE TO THE PATIENT OUTCOME: INSUFFICIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705167 ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL M0066802060 JRZ7435156 10816349011761

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other