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

Model Number	M006630205B1
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Responses to the end users questions regarding the guidewire materials and mri compatibility were provided.The device was not received for evaluation at the time of this report; therefore, no physical analysis of the device can be performed.Lot traceability was not provided.The lack of lot traceability prevents performing a device history records review for any indication of manufacturing defect or anomaly that could have impacted on the event as reported.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 needle.The dfu precautions also indicate, · 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.If there is any further relevant information provided, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: hello, please see copy of email from customer below - hope you can help me to find out what the zip wire is made up of ? i believe it is constructed from a metallic core with outer polymer coating.I just wanted to know whether its flexible tip contained any metal and is there any contraindication for the patient to undergo mri in the future as a part of his follow up treatments? unfortunately, a tiny bit of outer coating dislodged in one of our patient's kidneys while we tried to get access to a procedure called pcnl.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: unknown.What is the next course of action?: customer wants to know mri needs to occur.Patient present at time of event?: yes.Patient complications: no.Patient complications device acquired from a distributor?: no.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• 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: 16683143
• Report Number: 9680001-2023-00102
• Device Sequence Number: 8116268
• Product Code: EYA
• UDI-Device Identifier: 08714729761716
• UDI-Public: 08714729761716
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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: M006630205B1
• Device Catalogue Number: 66205
• 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: 03/20/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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