BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 18192770 · Received November 22, 2023

    Report

    Report Number
    9680001-2023-00122
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 30, 2023
    Report Date
    December 13, 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 149.8CM AND A FINISHED DIAMETER OF .03415" TO .03485". A GAGE BUSHING CERTIFIED TO BE .0355" WAS ABLE TO BE PASSED OVER THE LENGTH OF THE SPECIMEN UNTIL REACHING THE COATING DAMAGE. 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 WITH BLOOD-BANK SALINE, THE SPECIMEN WAS SUBJECTED TO VISUAL AND TACTILE EXAMINATION. THE SPECIMEN PRESENTED SKIVED/CUT DAMAGE AT APPROXIMATELY 18.5CM AND 35.0CM FROM THE DISTAL TIP. THE SPECIMEN PRESENTED LARGE RADIUS BEND DAMAGE AT APPROXIMATELY 7.0 CM FROM THE DISTAL TIP. NOTE, THE COMPLAINT NARRATIVE DOES NOT MENTION BEND DAMAGE, SO IT IS NOT POSSIBLE TO DETERMINE WHEN THIS DAMAGE OCCURRED. 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 AND 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. 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. ACCORDING TO THE ADDITIONAL INFORMATION PROVIDED ON NOVEMBER 14, 2023, "THE DEVICE WAS SENT BACK. YOU CAN REFER TO THE DEVICE RECEIVED." ADDITIONALLY, IT WAS REPORTED "UNKNOWN" IF THE ZIPWIRE WAS HYDRATED PER INSTRUCTIONS OUTLINED IN THE DIRECTIONS FOR USE (DFU). AS INDICATED IN THE 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION PROVIDED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 14, 2023: HOW MUCH OF THE "GUIDEWIRE'S OUTER SLEEVE WAS PEELED OFF"? --1CM. AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RECEIVED; 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 AND 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. AN IMAGE OF THE ACTUAL DEVICE WAS PROVIDED; HOWEVER, THE REPORTED DAMAGE COULD NOT BE CONFIRMED DURING REVIEW. ADDITIONALLY, IT WAS REPORTED "UNKNOWN" IF THE ZIPWIRE WAS HYDRATED PER INSTRUCTIONS OUTLINED IN THE DIRECTIONS FOR USE (DFU). AS INDICATED IN THE 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. 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 THE GUIDEWIRE'S OUTER SLEEVE WAS PEELED OFF. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE NOV. 22ND. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT CONDITION FOLLOWING PROCEDURE: STABLE EVENT RESOLVED: YES. REPORTED TIME OF EVENT: PREPARATION: ADDITIONAL INFORMATION PROVIDED 14 NOVEMBER 2023: 1. IS THERE A CLOSE-UP IMAGE OF THE REPORTED "PEELED" DAMAGE? YES, THE PICTURE WAS ATTACHED. AND THE DEVICE WAS SENT BACK. YOU CAN REFER TO THE DEVICE RECEIVED. 2. HOW MUCH OF THE "GUIDEWIRE'S OUTER SLEEVE WAS PEELED OFF"? 1CM. 3. THE REPORT INDICATES "PTFE" AND "PEELED". HAS THE BLACK POLYMER JACKET MATERIAL BEEN REMOVED AND/OR DAMAGED EXPOSING THE METAL CORE WIRE? PLEASE CLARIFY. UNK. 4. DID THE POLYMER JACKET MATERIAL DETACH WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE FROM THE DISPENSER HOOP? UNK. 5. WAS THE GUIDEWIRE HYDRATED OR RINSED WITH SALINE SOLUTION PRIOR TO REMOVAL FROM THE DISPENSER AS PER THE DFU? UNK.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: PER CNF: IT WAS REPORTED THAT THE GUIDEWIRE'S OUTER SLEEVE WAS PEELED OFF. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE (B)(6). THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT CONDITION FOLLOWING PROCEDURE - STABLE EVENT RESOLVED - YES. REPORTED TIME OF EVENT: PREPARATION. ADDITIONAL INFORMATION PROVIDED 14 NOVEMBER 2023: 1. IS THERE A CLOSE-UP IMAGE OF THE REPORTED "PEELED" DAMAGE? -YES, THE PICTURE WAS ATTACHED. AND THE DEVICE WAS SENT BACK. YOU CAN REFER TO THE DEVICE RECEIVED. 2. HOW MUCH OF THE "GUIDEWIRE'S OUTER SLEEVE WAS PEELED OFF"? --1CM. 3. THE REPORT INDICATES "PTFE" AND "PEELED". HAS THE BLACK POLYMER JACKET MATERIAL BEEN REMOVED AND/OR DAMAGED EXPOSING THE METAL CORE WIRE? PLEASE CLARIFY. UNK. 4. DID THE POLYMER JACKET MATERIAL DETACH WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE FROM THE DISPENSER HOOP? UNK. 5. WAS THE GUIDEWIRE HYDRATED OR RINSED WITH SALINE SOLUTION PRIOR TO REMOVAL FROM THE DISPENSER AS PER THE DFU? UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756862 ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES EYA LAKE REGION MEDICAL M0066802221 JRZ7662696 10816349011822

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male