MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491561
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
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.From risk assessment completed for this products failure mode it can be concluded that the failure mode is documented in the applicable dfmea, and the occurrence rate is being investigated under capa-06103.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, "emerging use" 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.
Event or Problem Description
Related product model #: 42415.Related product serial #: no value found.Related product upn #: m001491561.Related product batch/lot: 0009671426.Related product family: starter.Material number: m001491561.Sterile lot number: no value found.Sold to account number: no value found.Returned product expected: no.Bsc product return date: no value found.Location description: no value found.Device/procedure outcome: original device used, procedure completed patient outcome: f19: surgical intervention.Event description: per cnf, it was reported that: after ablation, the patient developed cardiac tamponade shortly after returning to the hospital ward, and an open chest procedure is scheduled on thursday.Note: for any patient information field(s) left blank in the cnf - "asked but not available as per account" infected: no infection name: diagnosis or treatment: resolution: completed with this device where did event occur: inside the patient outcome: adverse event first time the unit was used: tested prior to use: used before expiry date: generator used ablation[?]catheter used other used event date: 2026-1-30.As reported device codes: 2099: no known device problem.As reported patient codes: 9042: cardiac tamponade.

• 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: 24447438
• Report Number: 9681477-2026-00023
• Device Sequence Number: 10255097
• Product Code: DQX
• UDI-Device Identifier: 08714729326731
• UDI-Public: (01)08714729326731(17)280608(10)9671426
• 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): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M001491561
• Device Lot Number: 9671426
• 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: 02/04/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown