MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED Starter guidewire

Model Number	M001491561
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting the return of the device.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.
Event or Problem Description
Device/procedure outcome: procedure completed, unable to use device - attempted, different device used (same model) patient outcome: f26: no health consequences or impact.Event description: per cnf, it was reported that: "[?]"event"[?]"stuck guidewire "[?]"when did it occur?"[?]"during the procedure "[?]"what type of guidewire was used?"[?]"compatible guidewire "[?]"if the guidewire was a bsc device, what was the lot or j-pos number?"[?]""[?]"was a new guidewire used to continue the procedure or was the same guidewire used?"[?]"yes "[?]"was the guidewire removed as usual?"[?]"it was removed by force "[?]"did you experience any resistance while manipulating the guidewire?"[?]"yes "[?]"was the guidewire moved in and out of the catheter several times?"[?]"yes "[?]"how long was the coagulation time (act) when the stuck occurred?"[?]"300 "[?]"please describe in detail how it happened; during the procedure, when attempting to withdraw the guidewire, it could not be pulled back.The catheter itself could be removed, indicating that the guidewire was not caught in tissue.After removing the catheter, the guidewire was forcibly pulled out and removed; however, it was no longer usable.The catheter was then replaced, and the procedure was completed without further issues.In addition, the e-mail address of the physician, who was also the initial reporter, was not available.Infected: no infection name: diagnosis or treatment: resolution: different device used (same model) where did event occur: inside the patient outcome: no adverse event first time the unit was used: yes tested prior to use: yes used before expiry date: yes, physician's comment: generator used ablation"[?]"catheter used other used event date: 2026-4-6.As reported device codes: 1457: entrapment of device or device component as reported patient codes: 9398: no clinical signs, symptoms or conditions.

• 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: 25029656
• Report Number: 9681477-2026-00054
• Device Sequence Number: 10133518
• Product Code: DQX
• UDI-Device Identifier: 08714729326731
• UDI-Public: (01)08714729326731(17)280709(10)9895869
• 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,Followup
• Report Date (Section B): 08/26/2026

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: 9895869
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 04/08/2026; 08/18/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/01/2026; 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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