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

Model Number	M0066802080
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per medwatch voluntary mdr report # mw5185812 received 17 april 2026: tip of zipwire became lodged in the parenchyma of the patient.Information supplied by distributor 27 april 2026: product availability comment: device available for evaluation? yes.
Additional Manufacturer Narrative
Reference mdr report # mw5185812.Limited event details were provided.Follow up efforts were made to obtain additional information; however, no further event details have been received to date.According to the distributor, the product is available for evaluation; however, no product return information has been communicated to date.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 noted in the ifu 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.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appeared that procedural and/or 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.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.

• Brand Name: ZIPWIRE¿
• Common Device Name: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake region medical; 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: 25068965
• Report Number: 9680001-2026-00013
• Device Sequence Number: 16123774
• Product Code: EYA
• UDI-Device Identifier: 00816349011788
• UDI-Public: (01)00816349011788(17)280521(10)JRZ9889173
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M0066802080
• Device Catalogue Number: M0066802080
• Device Lot Number: JRZ9889173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown