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	10/27/2025
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 of the device can be performed.Attempts to gather additional event details have been made; however, to date no additional 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 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.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.(b)(6) 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.(b)(6) 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.
Event or Problem Description
Event description: per cnf, it was reported that at the end of the procedure, the coating was found to be detached.The patient condition following procedure was stable patient condition following procedure was stable.When was the problem noticed: procedure closure.Procedure outcome: completed with another of same device.Where did the problem occur? outside the patient.Action taken by the physician to try to resolve the event: none.Patient outcome from the event: none.Event resolved? yes.
Additional Manufacturer Narrative
This follow up report is being filed to due the evaluation of the actual device.The following sections have been updated: b4, d9, g3, g6, h2, h3, codes in h6 (b) and h11.As received, the specimen consisted of one-1 each pkg-hydro gw stf std s 150-035; returned reloaded into the dispenser assembly, bagged within "zip-lock" style poly biohazard pouch.The specimen presented an overall length of 150.8cm and a finished diameter of.03290" to.05550".A gage bushing certified to be.0350" passed over the length of the specimen with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity till the proximal aspect of skived/cut 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.Upon flushing the dispenser hoop with blood-bank saline, the specimen was easily removed and subjected to visual and tactile examination.The specimen coating appeared visually and tactilely consistent when examined at 1x - 18 inches, unaided, wet.The specimen presented skived/cut damage to the polymer jacket material, including metallic core wire exposure.The damage was located 16.4cm to 35.4cm from the distal tip.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 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.The customer-supplied image presented the guidewire within its dispenser assembly exhibiting skived/cut damage.This damage resulted in exposure of the metallic core wire at an undetermined distance from the distal tip, accompanied by removal of the surrounding polymer jacket.It was reported that the device was used with a metal cannula.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.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 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.Return information for the actual device has been requested.If any further relevant information is provided, a follow up medwatch report will be submitted.
Additional Manufacturer Narrative
This follow up report is being filed to due the receipt of additional information.The following sections have been updated: b4, b5, g3, g6, h2, codes in h6 (b), (c), (d) and h11.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.The customer-supplied image presented the guidewire within its dispenser assembly exhibiting skived/cut damage.This damage resulted in exposure of the metallic core wire at an undetermined distance from the distal tip, accompanied by removal of the surrounding polymer jacket.It was reported that the device was used with a metal cannula.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.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 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.Return information for the actual device has been requested.To date there is no update on the return.If any further relevant information is provided, a follow up medwatch report will be submitted.
Event or Problem Description
Additional information and image provided (b)(6) 2025: 1.Is there an image of the reported defect?--yes.2.Listing and model of other devices used during the procedure, include the model, brand name, sizes, etc.: basket model: m0063901050 specification: 1.9f brand: bsc 2.Ureteral sheath model: m0062502220 specification: 11/13f * 36cm brand: bsc.3.Was the zipwire advanced through a metal cannula or needle?--- metal cannula.4.Did the physician encounter any resistance while advancing the zipwire to its intended location?---no.5.Did the physician encounter any resistance while removing the zipwire?---yes.6.Were there any patient complications due to the reported malfunction?---no.7.Did any part of the guidewire detach inside the patient?---no.8.Is the metal core wire exposed?---yes.9.By "coating was detached" did you mean the ptfe peeled?---yes.

• 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: 23708281
• Report Number: 9680001-2025-00023
• Device Sequence Number: 21495236
• Product Code: EYA
• UDI-Device Identifier: 00816349011825
• UDI-Public: (01)00816349011825(17)270815(10)JRZ9266850
• 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,Followup
• Report Date (Section B): 01/09/2026

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: JRZ9266850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 01/05/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/29/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 79 KG