BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 14802594 · Received June 24, 2022

    Report

    Report Number
    9680001-2022-00107
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    May 12, 2022
    Report Date
    July 13, 2022
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    EYA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, 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. EXCESSIVE MANIPULATION OF THE ZIPWIRE HYDROPHILIC GUIDEWIRE WITHOUT FLUOROSCOPIC CONFIRMATION MAY RESULT IN PERFORATION OR TRAUMA OF THE LININGS OR ASSOCIATED TISSUES, CHANNELS OR DUCTS. IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEM 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. USE EXTREME CAUTION 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. 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 APPEARS THAT CLINICAL AND/OR PROCEDURAL FACTORS IMPACTED ON THE EVENT AS REPORTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION PROVIDED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ON 12 JULY 2022 OUR DISTRIBUTOR PROVIDED THREE POSSIBLE LOT NUMBERS FOR THE INVOLVED DEVICE AND REQUESTED A DEVICE HISTORY RECORD REVIEW FOR EACH LOT. ALL LOT NUMBERS PROVIDED INDICATE CHASKA, MN USA AS THE PLACE OF MANUFACTURE AND NOT JUAREZ, MEXICO AS ORIGINALLY REPORTED. THIS REPORT IS BEING FILED AS A CORRECTION AND TO REFERENCE THE MDR BEING FILED BY CHASKA FOR THIS INCIDENT UNDER REPORT NUMBER 2126666-2022-00028.

    Description of Event or Problem · 0

    PER USER MEDWATCH REPORT 3900320000-2022-8004: DESCRIBE THE EVENT OR PROBLEM: THE PATIENT WAS BROUGHT TO THE OR FOR A CYSTO RETROGRADE PYELOGRAM (RPG) LITHOTRIPSY WITH HOLMIUM LASER AND STENT PLACEMENT. TOWARDS THE END OF THE PROCEDURE THE OR TECH NOTICED THAT THE GUIDE WIRE WAS NOT INTACT AND THAT THE "FLOPPY" PORTION OF THE WIRE WAS MISSING. THIS WAS BROUGHT TO THE MDS ATTENTION & THE CIRCULATING NURSE AND THE X-RAY TECH CORROBORATE THIS INTERACTION. THE MD THEN USED THE BROKEN WIRE ON HAND. A POST OP FILM WAS TAKEN, THE PATIENT WENT TO PACU. THE X-RAY TECH SUGGESTED THAT THERE MIGHT BE A PORTION OF WIRE STILL IN THE KIDNEY/URETER. THE DR CONFIRMED THE WIRE WAS STILL RETAINED AND THE PATIENT WAS TAKEN BACK TO THE CYSTO ROOM FOR THE FOREIGN BODY EXTRACTION. DURING THE SECOND PROCEDURE THE WIRE WAS EXTRACTED (A 12" PORTION OF THE 60" ZIPWIRE) AND A NEW STENT WAS INSERTED. THE PATIENT WAS THEN TAKEN BACK TO PACU AND SUBSEQUENTLY DISCHARGED IN GOOD CONDITION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : CYSTO RPG LITHOTRIPSY WITH HOLMIUM LASAR AND STENT PLACEMENT.

    Description of Event or Problem · 0

    PER USER MEDWATCH REPORT (B)(4): DESCRIBE THE EVENT OR PROBLEM: THE PATIENT WAS BROUGHT TO THE OR FOR A CYSTO RETROGRADE PYELOGRAM (RPG) LITHOTRIPSY WITH HOLMIUM LASER AND STENT PLACEMENT. TOWARDS THE END OF THE PROCEDURE THE OR TECH NOTICED THAT THE GUIDE WIRE WAS NOT INTACT AND THAT THE "FLOPPY" PORTION OF THE WIRE WAS MISSING. THIS WAS BROUGHT TO THE MDS ATTENTION & THE CIRCULATING NURSE AND THE X-RAY TECH CORROBORATE THIS INTERACTION. THE MD THEN USED THE BROKEN WIRE ON HAND. A POST OP FILM WAS TAKEN, THE PATIENT WENT TO PACU. THE X-RAY TECH SUGGESTED THAT THERE MIGHT BE A PORTION OF WIRE STILL IN THE KIDNEY/URETER. THE DR CONFIRMED THE WIRE WAS STILL RETAINED AND THE PATIENT WAS TAKEN BACK TO THE CYSTO ROOM FOR THE FOREIGN BODY EXTRACTION. DURING THE SECOND PROCEDURE THE WIRE WAS EXTRACTED (A 12" PORTION OF THE 60" ZIPWIRE) AND A NEW STENT WAS INSERTED. THE PATIENT WAS THEN TAKEN BACK TO PACU AND SUBSEQUENTLY DISCHARGED IN GOOD CONDITION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: CYSTO RPG LITHOTRIPSY WITH HOLMIUM LASAR AND STENT PLACEMENT ON (B)(6) 2022 OUR DISTRIBUTOR PROVIDED THREE POSSIBLE LOT NUMBERS FOR THE INVOLVED DEVICE AND REQUESTED A DEVICE HISTRORY RECORD REVIEW FOR EACH LOT. ALL LOT NUMBERS PROVIDED INDICATE CHASKA, MN USA AS THE PLACE OF MANUFACTURE AND NOT JUAREZ, MEXICO AS ORIGINALLY REPORTED. THIS MEDWATCH REPORT SHOULD BE CONSIDERED VOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056922 ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention| O