BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 18170773 · Received November 20, 2023

    Report

    Report Number
    9680001-2023-00121
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 13, 2023
    Report Date
    December 7, 2023
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    EYA
    UDI-DI
    10816349011822
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION. AS RECEIVED, THE SPECIMEN CONSISTED OF ONE-1 EACH PKG-HYDRO GW STF STD S 150-035; RETURNED WITHIN THE DISPENSER ASSEMBLY; DOUBLE BAGGED WITHIN "ZIP-LOCK" STYLE POLY BIOHAZARD POUCH. THE SPECIMEN PACKAGING LABEL WAS ALSO RETURNED WITH THE DEVICE. THE SPECIMEN PRESENTED AN OVERALL LENGTH OF APPROXIMATELY 150.1CM AND A FINISHED DIAMETER OF .03215" TO .03400". A GAGE BUSHING CERTIFIED TO BE .0350" PASSED OVER THE LENGTH OF THE SPECIMEN WITH NO MORE EFFORT THAN THE MASS OF THE BUSHING SLIDING DOWN THE WIRE SHAFT UNAIDED, EXCEPT BY GRAVITY. NOTE ALL DIAMETER MEASUREMENTS WERE ACQUIRED WITH A NON-CONTACT, TOOLMAKERS SCOPE AFTER ALLOWING THE SPECIMEN DEVICE TO BECOME DRY AFTER HYDRATING THE SPECIMEN DEVICE WITH BLOOD-BANK SALINE. AFTER FLUSHING THE DISPENSER WITH BLOOD-BANK SALINE, THE SPECIMEN WAS EASILY REMOVED FROM THE DISPENSER ASSEMBLY AND WAS SUBJECTED TO VISUAL AND TACTILE EXAMINATION. THE SPECIMEN COATING APPEARED VISUALLY AND TACTILELY CONSISTENT WHEN EXAMINED AT 1X - 18 INCHES, UNAIDED, WET. THE SPECIMEN PRESENTED A DUCTILE/TENSILE OVERLOAD FRACTURE OF THE POLYMER JACKET WITH MATERIAL REMOVAL EXPOSING THE DISTAL 0.03CM OF THE METALLIC CORE WIRE; THE POLYMER JACKET MATERIAL DISTAL OF THE FRACTURE WAS NOT RETURNED WITH THE SPECIMEN. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARED VISUALLY AND DIMENSIONALLY CORRECT. 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 CUSTOMER SUPPLIED THE IMAGE PRESENTED A DUCTILE/TENSILE OVERLOAD FRACTURE OF THE POLYMER JACKET WITH AN UNKNOWN LENGTH OF MATERIAL REMOVAL, EXPOSING THE METALLIC CORE WIRE AT THE TIP. AS INDICATED IN THE DIRECTIONS FOR USE (DFU) PRECAUTIONS, "THE SURFACE OF THE ZIPWIRE HYDROPHILIC GUIDEWIRE IS NOT LUBRICIOUS UNLESS IT IS WET. BEFORE TAKING IT OUT OF ITS HOLDER AND INSERTING IT THROUGH A CATHETER, FILL THE HOLDER AND THE CATHETER WITH STERILE PHYSIOLOGICAL SALINE SOLUTION." AS NOTED IN THE DFU OPERATIONAL INSTRUCTIONS, "TO ACTIVATE HYDROPHILIC COATING: BEFORE REMOVING THE ZIPWIRE HYDROPHILIC GUIDEWIRE FROM THE PROTECTIVE HOOP (BY ITS DISTAL END), INJECT PHYSIOLOGICAL SALINE SOLUTION INTO THE HUB END OF THE HOLDER IN ORDER TO COMPLETELY WET THE SURFACE OF THE WIRE." 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 HANDLING FACTORS HAVE CONTRIBUTED TO THE EVENT AS REPORTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE HAS NOT BEEN RETURNED; 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. THE CUSTOMER SUPPLIED THE IMAGE PRESENTED A DUCTILE/TENSILE OVERLOAD FRACTURE OF THE POLYMER JACKET WITH AN UNKNOWN LENGTH OF MATERIAL REMOVAL, EXPOSING THE METALLIC CORE WIRE AT THE TIP. AS INDICATED IN THE DIRECTIONS FOR USE (DFU) PRECAUTIONS, "THE SURFACE OF THE ZIPWIRE HYDROPHILIC GUIDEWIRE IS NOT LUBRICIOUS UNLESS IT IS WET. BEFORE TAKING IT OUT OF ITS HOLDER AND INSERTING IT THROUGH A CATHETER, FILL THE HOLDER AND THE CATHETER WITH STERILE PHYSIOLOGICAL SALINE SOLUTION." AS NOTED IN THE DFU OPERATIONAL INSTRUCTIONS, "TO ACTIVATE HYDROPHILIC COATING: BEFORE REMOVING THE ZIPWIRE HYDROPHILIC GUIDEWIRE FROM THE PROTECTIVE HOOP (BY ITS DISTAL END), INJECT PHYSIOLOGICAL SALINE SOLUTION INTO THE HUB END OF THE HOLDER IN ORDER TO COMPLETELY WET THE SURFACE OF THE WIRE." AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE EVENT INFORMATION RECEIVED TO DATE, IT APPEARS THAT HANDLING DURING PREPARATION 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: PER CNF: IT WAS REPORTED THAT WHEN UNPACKED, IT WAS FOUND THAT THE COATING ON THE TIP OF THE GUIDEWIRE WAS PEELED OFF. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE NOV.20TH. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT CONDITION FOLLOWING PROCEDURE - STABLE. WHEN WAS THE PROBLEM NOTICED: UNPACKING. EVENT RESOLVED - YES. ADDITIONAL INFORMATION PROVIDED 8 NOVEMBER 2023: 1. CLOSE UP IMAGE OF REPORTED DAMAGED PROVIDED. 2. THE WIP REPORT INDICATES "DETACHMENT". PLEASE CLARIFY. UNK. 3. DID THE POLYMER JACKET MATERIAL DETACH WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE FROM THE DISPENSER HOOP? YES. 4. IS THE METAL CORE WIRE EXPOSED? YES. 5. WAS THE GUIDEWIRE HYDRATED OR RINSED WITH SALINE SOLUTION PRIOR TO REMOVAL FROM THE DISPENSER AS PER THE DFU? YES.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: PER CNF: IT WAS REPORTED THAT WHEN UNPACKED, IT WAS FOUND THAT THE COATING ON THE TIP OF THE GUIDEWIRE WAS PEELED OFF. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE NOV.20TH. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT CONDITION FOLLOWING PROCEDURE - STABLE. WHEN WAS THE PROBLEM NOTICED: UNPACKING. EVENT RESOLVED - YES. ADDITIONAL INFORMATION PROVIDED 8 NOVEMBER 2023: 1. CLOSE UP IMAGE OF REPORTED DAMAGED PROVIDED. 2. THE WIP REPORT INDICATES "DETACHMENT". PLEASE CLARIFY, UNK. 3. DID THE POLYMER JACKET MATERIAL DETACH WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE FROM THE DISPENSER HOOP? YES. 4. IS THE METAL CORE WIRE EXPOSED? YES. 5. WAS THE GUIDEWIRE HYDRATED OR RINSED WITH SALINE SOLUTION PRIOR TO REMOVAL FROM THE DISPENSER AS PER THE DFU? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021459 ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL M0066802221 JRZ7549646 10816349011822

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male