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

Model Number	M0066802220
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: it was reported that: before the device was unpacked, it was found hair inside.The device is expected to be returned around may.14th.The patient condition following procedure was stable.What was the patient condition following procedure? stable when was the problem noticed: unpacking where did the problem occur? outside the patient action taken by the physician to try to resolve the event: observation patient outcome from the event: none procedure outcome: completed with another of same device event resolved? yes photo provided (b)(6) 2026.
Additional Manufacturer Narrative
The distributor indicated that the physician first name, phone, and email address were asked but not available as per account/customer.Therefore, the respective fields are blank within section e1.This report is being submitted in good faith based on the information currently available.At the time of this report, no product has been returned for evaluation; however, a customer-supplied image was provided.The image includes a circled area highlighting the reported issue.Review of this area appears to show a single strand of hair located in the corner of the pouch.It should be noted that the image does not depict the entire sealed pouch; only the localized area containing the reported hair is visible.As a result, it is not possible to confirm the overall condition or integrity of the packaging.An additional request for an image of the complete sealed pouch has been made; however, no further images have been received 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.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The packaging operation takes place in a cleanroom environment with strict gowning requirements.Additionally, operators are required to perform 100% visual inspection of the product and packaging prior to release for shipment.Based on the available information, the reported contamination cannot be definitively confirmed, and the source of the observed hair cannot be determined.At this time, a definitive root cause cannot be established.Lake region's effectiveness of design verification activities brings the overall risk down to as far as possible.We 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.Efforts to obtain additional information, including return of the complaint device, are ongoing.Should additional relevant information become available, 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 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: 25164295
• Report Number: 9680001-2026-00016
• Device Sequence Number: 10474197
• Product Code: EYA
• UDI-Device Identifier: 00816349011825
• UDI-Public: (01)00816349011825(17)271217(10)JRZ9518509
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: JRZ9518509
• 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: 04/22/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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 Age: 35 YR
• Patient Sex: Male
• Patient Weight: 60 KG