MAUDE Adverse Event Report: Lake Region Medical Limited Starter guidewire

Model Number	M001491561
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: we received a defective item; the following information is provided: product: m001491561 upn: m001491561 - rosen guide 0.035 j tip 1.5mm lot number: 8315979 model: m001491561 bsc notification date: 08/28/2026 product available for return? yes note: guide wire disintegrated upon insertion into the catheter.· what type of procedure was performed? faraview ablation date: 08/19/2026 · what was the specific anatomical location? left atrium · when did the incident occur (e.G., during the procedure, during preparation/before use, etc.)? during the procedure · what was used to complete the procedure (this device, another device of the same type, a different device (different model))? was another device of the same type used? · were there any complications for the patient resulting from this event? no · did the patient's clinical condition remain stable after the procedure? yes what was the outcome of the procedure (procedure successfully completed, procedure canceled, completed by an alternative method)? procedure successfully completed.Material is available for analysis.Yes · please provide the following information about the physician: first and last name, clinic name, phone number, email, fax, address, zip code.Not available per client.Event date: 2026-8-19.
Additional Manufacturer Narrative
Awaiting device return.

• 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: 50876653
• Report Number: 9681477-2026-00120
• Device Sequence Number: 10716285
• Product Code: DQX
• UDI-Device Identifier: 08714729326731
• UDI-Public: (01)08714729326731(17)270207(10)8315979
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/24/2026

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: 8315979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• 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 Sex: Unknown