MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE¿; UROLOGICAL CATHETER AND ACCESSORIES

Model Number	M0066802050
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that patient information was "unavailable" and noted that the gender identity was requested, but also reported as "not available." therefore, part a of this report is blank.The device was reported to be available for analysis; however, as of this report the device has not be returned.The customer supplied image presented skived/cut damage by exposing core wire at an unknown distance from the distal tip.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: 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 style needle.As noted in the device instructions for use (dfu) precautions: 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.Based on the information provided, it appeared that procedural and/or handling factors have contributed to the event as reported.If any further relevant information is provided, a follow up medwatch report will be submitted.Note: although annex g instructions state that with stand-alone devices annex g term should not be used, code 4755 was selected due to component code (g) showing up on the missing data report.
Event or Problem Description
Event description: physician was getting access and using the zipwire through the naviguide access needle.Physician believes that the wire got pinned between the stone and the naviguide needle and when he was pulling the wire out, the needle and stone compressed the wire and sheered off some of the wire.There were two 'ribbons' of wire.Physician was able to extract both pieces and will return in package with damaged wire.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? no troubleshooting took place.What is the next course of action? replace product.Patient present at time of event? yes.Patient complications: no patient complications.Time of the event: during procedure.What was the outcome of the procedure? procedure completed using an alternate method.Additional information provided 26 november 2024: 1.What are the listing and model of other devices used during the procedure, include the model, brand name, sizes, etc.? naviguide needle m0067001330.2.Is the "naviguide access needle" a metal needle? yes, it is our needle.3.The narrative indicates that both pieces of the sheared off wire were extracted.What method was used to retrieve the pieces? graspers.4.Please confirm or clarify on the condition of the patient after the procedure was (good, stable, fine, etc.)? great.No issues with patient.

• Brand Name: ZIPWIRE¿
• Common Device Name: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): VENUSA DE MEXICO S. DE R.L. DE C.V.; calle hertz 1525; parque industrial a j bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer Contact: victoria foss ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 20784870
• Report Number: 9680001-2024-00029
• Device Sequence Number: 5004542
• Product Code: EYA
• UDI-Device Identifier: 00816349011757
• UDI-Public: (01)00816349011757(17)270719(10)JRZ9196488
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0066802050
• Device Catalogue Number: M0066802050
• Device Lot Number: JRZ9196488
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown