MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491561
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for analysis.A review of the device history records for the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint is non-verifiable as the product was not returned for evaluation.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "device interaction", "improper handling" and/or "undetermined cause" appears to have impacted on the event as reported.Without the return of the actual device in question for evaluation, lake region medical is unable to determine the exact cause for this incident.Lake region medical has no open preventative action specific to manufacturing this product differently.As indicated in the ifu (instructions for use) precautions section: never advance the guidewire against resistance without first determining the reason for resistance under fluoroscopy.
Event or Problem Description
Event description: ecn event description: farawave opened and prepped on back table with no issue.Farawave inserted into 13f agilis sheath, rosen wire was difficult to advance out past the tip of the device (catheter was still in sheath, attempting to lead with wire).Farawave was removed and new rosen wire was used.Catheter was re-inserted along with wire, guided up to la.Ablations started at lspv in 'basket' no issue.Physician deployed 'flower' and tried to advance wire further into vein, noticed significant resistance when either advancing or retracting wire.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: swapped out rosen for new guidewire checked for occlusion by manually flushing guidewire lumen with syringe no occlusion noted.What is the next course of action?: new farawave catheter opened.Patient present at time of event?: yes patient complications: no patient complications patient outcome: fully recovered procedure number: (b)(4) event date: 2026-3-4 as reported device codes: 1274: difficult to advance as reported patient codes: 9398: no clinical signs, symptoms or conditions country of event: united states related product upn #: m001491561 related product batch/lot: 0010019370 related product family: starter material number: m001491561.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross, co. wexford Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross, co. wexford Y34 K 825; EI Y34 K825
• Manufacturer Contact: suzanne foley ; butlersland; new ross, co. wexford Y34 K-825 ; EI Y34 K825
• MDR Report Key: 24602966
• Report Number: 9681477-2026-00039
• Device Sequence Number: 15854578
• Product Code: DQX
• UDI-Device Identifier: 08714729326731
• UDI-Public: (01)08714729326731(17)281011(10)10019370
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K935170
• 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): 03/16/2026

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: M001491561
• Device Lot Number: 10019370
• 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: 03/06/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2025
• 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
• Patient Sex: Unknown