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 Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	09/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Event description: ecn event description: the tension dropped when passing to the right we had time to do the first balloon application before seeing that the tension was much too low and therefore effusion.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: no troubleshooting needed what is the next course of action?: just to hear from the patient patient present at time of event?: yes adverse/unintended patient events: cardiac tamponade in the physician's opinion, did the device or procedure contribute to the adverse or unintended patient event?: yes please explain how the device or procedure contributed?: because of the j tip medical or surgical interventions: chest surgery reason for unsuccessful procedure: the patient's blood pressure has dropped based on the outcome noted above, was the patient sedated when the procedure was cancelled?: yes - general anesthesia device acquired from a distributor?: no.Event date: 2026-9-7.
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.

• 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: 50855970
• Report Number: 9681477-2026-00122
• Device Sequence Number: 15829619
• Product Code: DQX
• UDI-Device Identifier: 08714729326731
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/22/2026

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: 10418438
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2026
• 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
• Patient Sex: Unknown