BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 11726609 · Received April 26, 2021

    Report

    Report Number
    2126666-2021-00012
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Report Date
    May 12, 2021
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    EYA
    UDI-DI
    08714729761785
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT DEVICE RECEIVED (B)(6) 2021. DEVICE EVALUATION: AS RECEIVED, THE SPECIMEN CONSISTED OF ONE-1 EACH HYDRO GW STD AN 150-038; RETURNED COILED, LOOSE AND DOUBLE-BAGGED WITHIN "ZIP-LOCK" STYLE POLY BIOHAZARD POUCHES. THE SPECIMEN PRESENTED MELT DAMAGE TO THE POLYMER JACKET AND METALLIC CORE WIRE LOCATED 3.20 TO 4.40CM FROM THE DISTAL TIP WHILE THE SPECIMEN DEVICE WAS UNDER TENSION RESULTING IN A CORE WIRE SEPARATION 3.85CM FROM THE DISTAL TIP AND A LARGE RADIUS BEND OVER THE 10.25CM PROXIMAL OF THE CORE WIRE SEPARATION. 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 ABOVE, THE SPECIMEN PRESENTED MELT DAMAGE TO THE POLYMER JACKET AND METALLIC CORE WIRE LOCATED 3.20 TO 4.40CM FROM THE DISTAL TIP WHILE THE SPECIMEN DEVICE WAS UNDER TENSION RESULTING IN A CORE WIRE SEPARATION 3.85CM FROM THE DISTAL TIP AND A LARGE RADIUS BEND OVER THE 10.25CM PROXIMAL OF THE CORE WIRE SEPARATION. THE MELT AND SEPARATION DAMAGE TO THE SPECIMEN APPEARED CONSISTENT WITH CONTACT WITH A LASER BEAM OR A CAUTERY TOOL. THERE IS NOTHING IN THE MANUFACTURING PROCESS THAT COULD CAUSE THE DAMAGE PRESENTED BY THE SPECIMEN. OUR INVESTIGATION WAS UNABLE TO CONFIRM THAT THE PRODUCT DID NOT MEET SPECIFICATION PRIOR TO SHIPMENT. THE INVESTIGATION CONCLUDED THAT THE PRODUCT MET SPECIFICATION AT THE TIME OF SHIPMENT. THE DEVICE INSTRUCTIONS FOR USE WARNINGS SECTION INDICATES: -USE EXTREME CARE WHEN USING A LASER, MAKING SURE TO AVOID CONTACT WITH THE ZIPWIRE HYDROPHILIC GUIDEWIRE. DIRECT CONTACT MAY CAUSE DAMAGE TO THE WIRE AND/OR SEVER THE WIRE. -MANIPULATE THE ZIPWIRE HYDROPHILIC GUIDEWIRE SLOWLY AND CAREFULLY IN THE URINARY SYSTEM WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY. IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE WIRE AND/OR CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING SEPARATION OF THE ZIPWIRE HYDROPHILIC GUIDEWIRE'S TIP DAMAGE TO THE CATHETER OR DAMAGE TO THE URINARY SYSTEM. IF NECESSARY, REMOVE THE ZIPWIRE HYDROPHILIC GUIDEWIRE AND ANCILLARY DEVICE OR SCOPE AS A COMPLETE UNIT TO AVOID COMPLICATIONS. MULITPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL EVENT AND PATIENT INFORMATION FROM THE END-USER. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT INFORMATION AND EVENT DATE WERE NOT PROVIDED AT THE TIME OF THIS REPORT. ADDITIONALLY, 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 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. THE DEVICE INSTRUCTIONS FOR USE WARNINGS SECTION INDICATES, "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." THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED, CLINICAL AND/OR PROCEDURAL FACTORS APPEAR TO HAVE IMPACTED ON THE EVENT AS REPORTED. IF ANY FURTHER INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: THE GUIDEWIRE BROKE DURING A PROCEDURE. A SMALL PIECE OF IT WAS IN THE PATIENT THANKFULLY STAFF WERE ABLE TO GET THE SMALL PIECE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620984 ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL M006630209B1 5705116 08714729761785

    Patients

    Seq Age Sex Outcome Treatment
    1