MAUDE Adverse Event Report: Lake Region Medical Limited Starter guidewire

Model Number	M001491561
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: per cnf, it was reported that: -event; damage -was there any appearance abnormality before use?"[?]" no -at what location and what kind of damage was observed?"[?]" the insulation has peeled off, and the internal wire was exposed.Note: for any patient information field(s) left blank in the cnf - 'asked but not available as per account.In addition, the e-mail address of the physician, who was also the initial reporter, was not available.Physician comments: patient outcome: no adverse event infected: no generator/controller: ablation catheter used: other used: event date: 2026-8-25.
Additional Manufacturer Narrative
Awaiting the return of the device.

• Brand Name: Starter guidewire
• Common Device Name: Starter guidewire
• Manufacturer (Section D): Lake Region Medical Limited; butlersland; new ross; co. wexford, irl Y34 K 825; EI Y34 K825
• Manufacturer (Section G): Lake Region Medical Limited; butlersland; new ross; co. wexford, irl Y34 K 825; EI Y34 K825
• Manufacturer Contact: katie slattery ; butlersland; new ross; co. wexford, irl Y34 K-825 ; EI Y34 K825
• MDR Report Key: 50789673
• Report Number: 9681477-2026-00115
• Device Sequence Number: 9415981
• Product Code: DQX
• UDI-Device Identifier: 08714729326731
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/16/2026

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: 10019460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/29/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2025
• 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