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

Model Number	M0066802220
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this report, no product has been returned for evaluation.Therefore, no physical analysis can be performed.Additional event information, including product status has been requested.However, to date no new information has been provided.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 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: prior to use, carefully examine the unit to verify that neither the contents nor the sterile package has been damaged in shipment.The zipwire hydrophilic guidewire is a delicate instrument and should be handled carefully.Prior to use and when possible, during the procedure, inspect the wire carefully for bends or kinks which may have occurred.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, it appears that handling factors have contributed to the event as reported.Lake region medical reviewed the associated risk documentation relative to this product and confirmed that this incident is listed and that it is trending within the established occurrence threshold.Lake region's effectiveness of design verification activities brings the overall risk down to as far as possible.If any further relevant information is provided, a follow up medwatch report will be submitted.If there is any further relevant information 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: when the physician opened the package, the guide wire inside was fractured by pulling, and then the tip fell off.The patient condition following procedure was stable.What was the patient condition following procedure? stable.Event resolved: yes.Action taken by the physician to try to resolve the event: observation.Patient outcome from the event: none.When was the problem noticed: unpacking.Where did the problem occur? outside the patient.Procedure outcome: completed with another of same device.
Additional Manufacturer Narrative
This follow up report is being filed due to the receipt of additional information regarding product status.The following sections have been updated: b4, b5, d9, g3, g6, h2, h6 (b) and h11.It was confirmed that no product would return for evaluation.Without the return of the actual device, no visual or physical analysis of the product could 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.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: prior to use: carefully examine the unit to verify that neither the contents nor the sterile package has been damaged in shipment.The zipwire hydrophilic guidewire is a delicate instrument and should be handled carefully.Prior to use and when possible, during the procedure, inspect the wire carefully for bends or kinks which may have occurred.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, it appears that handling factors have contributed to the event as reported.Lake region medical reviewed the associated risk documentation relative to this product and confirmed that this incident is listed and that it is trending within the established occurrence threshold.Lake region's effectiveness of design verification activities brings the overall risk down to as far as possible.If any further relevant information is provided, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: when the physician opened the package, the guide wire inside was fractured by pulling, and then the tip fell off.The patient condition following procedure was stable.What was the patient condition following procedure? stable.Event resolved? yes.Action taken by the physician to try to resolve the event: observation.Patient outcome from the event: none.When was the problem noticed: unpacking.Where did the problem occur? outside the patient.Procedure outcome: completed with another of same device.Additional information provided 4 march 2026: is zipwire returning? no, it is no longer available for return.Do you have a photo of the guidewire used? no, confirmed via previous phone call.

• 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 hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 24429163
• Report Number: 9680001-2026-00008
• Device Sequence Number: 10253911
• Product Code: EYA
• UDI-Device Identifier: 00816349011825
• UDI-Public: (01)00816349011825(17)271011(10)JRZ9384653
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 03/04/2026

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: M0066802220
• Device Catalogue Number: M0066802220
• Device Lot Number: JRZ9384653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• 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