BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 14193717 · Received April 25, 2022

    Report

    Report Number
    2126666-2022-00019
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Report Date
    April 25, 2022
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    EYA
    UDI-DI
    08714729761761
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS RECEIVED, THE SPECIMEN CONSISTED OF ONE-1 EACH HYDRO GW STD S 150-035; RETURNED COILED, LOOSE AND ACCOMPANIED BY THE RECOVERED, DETACHED POLYMER JACKET MATERIAL FROM THE CLINICAL EVENT AND TRIPLE-BAGGED WITHIN "ZIP-LOCK" STYLE POLY POUCHES. THE SPECIMEN PRESENTED AN OVERALL LENGTH OF 149.00CM DUE TO THE FRACTURE DAMAGE PRESENTED, AND A FINISHED DIAMETER OF .03365" (PROXIMAL OF THE SKIVE/CUT DAMAGE) TO .03380". THE SPECIMEN PRESENTED 10.45CM OF THE POLYMER JACKET MATERIAL SKIVED/CUT FROM THE DISTAL REGION OF THE SPECIMEN WIRE EXPOSING 8.80CM OF THE METALLIC CORE WIRE WITH INDICATIONS OF A DUCTILE, TENSILE OVERLOAD AT THE DISTAL END OF THE EXPOSED CORE WIRE. THE SPECIMEN ALSO PRESENTED INCREASING RADIUS BEND DAMAGE OVER THE DISTAL 10.80CM; CONSISTENT WITH TENSILE LOADING. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARED VISUALLY AND DIMENSIONALLY CORRECT. THE EVIDENCE PRESENTED BY THE SPECIMEN INDICATED THE CORE WIRE SUSTAINED AN OVERLOAD FRACTURE APPROXIMATELY 1CM FROM THE DISTAL TIP DURING THE TENSILE LOADING INDUCED BY THE SKIVE/CUT ACTION INCURRED DURING THE CLINICAL EVENT. 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. 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. 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

    PER EMAIL, IT WAS REPORTED THAT: SURGEON UTILIZED THIS WIRE TO ASSIST WITH PLACING A RIGHT SUBCLAVIAN INFUSAPORT. IT WAS NOTED BY THE SCRUB TECH THAT THE HYDROPHILIC COATING WAS UNINTENTIONALLY RETAINED IN THE PATIENT. SURGEON WAS ABLE TO RETRIEVE THIS BROKEN OFF PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796265 ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL M006630205B1 5976810 08714729761761

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown