MAUDE Adverse Event Report: Lake Region Medical Limited Starter guidewire

Model Number	M001491561
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Ecn event description: ablations performed in left pulmonary veins, no issues noted.Physician having issues attempting to wire rpvs.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: deployed 'flower' conformation when farawave catheter partially in sheath.Non-recoverable.What is the next course of action?: new farawave catheter opened.Patient present at time of event?: yes.
Event or Problem Description
Event description: ecn event description: ablations performed in left pulmonary veins, no issues noted.Physician having issues attempting to wire rpvs.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: deployed 'flower' conformation when farawave catheter partially in sheath.Non-recoverable.What is the next course of action?: new farawave catheter opened.Patient present at time of event?: yes.Event date: (b)(6) 2026.
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.
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.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.As indicated in the ifu (instructions for use) precautions section: · prior to use, all equipment to be used for the procedure should be carefully examined to verify proper function and integrity.

• 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: 50298101
• Report Number: 9681477-2026-00106
• Device Sequence Number: 9705773
• Product Code: DQX
• UDI-Device Identifier: 08714729326731
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/16/2026

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: 10418485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/29/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2026
• 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