MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED Starter guidewire

Model Number	M001491561
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: per cnf, it was reported that: around the rspv, the wire was once retracted into the catheter, and when an attempt was made to anchor it again, it got stuck, the wire protruded slightly from the tip and it could no longer be advanced.While pulling back the catheter and sheath, the catheter was safely retracted into the sheath, and it was removed from the body, part of the fiber like structure was found caught at the tip of the wire lumen; therefore, the catheter and wire were replaced, and the event was resolved.At present, there is no information indicating any complications.Note: for any patient information field(s) left blank in the cnf: 'asked but not available as per account.' in addition, the email addresses of both the physician and the initial reporter were not available.Physician comments: patient outcome: no adverse event infected: no generator/controller: ablation catheter used: other used: device/procedure outcome: procedure completed, unable to use device.Attempted, different device used (same model).Patient outcome: f26: no health consequences or impact.As reported device codes: 1457: entrapment of device or device component.As reported patient codes: 9398: no clinical signs, symptoms or conditions.
Additional Manufacturer Narrative
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.Awaiting device return.

• Brand Name: Starter guidewire
• Common Device Name: Starter 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, 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: 24575212
• Report Number: 9681477-2026-00033
• Device Sequence Number: 21191029
• 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,Followup
• Report Date (Section B): 08/10/2026

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: 9671429
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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