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	08/06/2026
Type of Reportable Event	Death
Event or Problem Description
Event description: per cnf, it was reported that: event: a patient injury has occurred.Please indicate the details of patient injury observed into the patient: cardiac tamponade.Please indicate the details about the event that leads to patient injury.During the bb procedure, there was a pacemaker lead located near the septum, which caused difficulties; after one unsuccessful attempt, the procedure was repeated after repositioning and was successful.During the pvi procedure, the procedure was carried out in the order ls, li, ri; whilst performing ripv, it was discovered that the blood pressure was dropping whilst repositioning several times, and treatment for cardiac tamponade was initiated.Please indicate the details about the treatment for the patient injury that occurred.After performing the drainage procedure, information regarding the decision on whether to proceed to surgery is not available.Please indicate the condition of the patient after the treatment.Unknown.Please indicate the view of the attending physician regarding the cause on the occurrence of patient injury.Unknown.Was there a problem with the appearance or functionality of this device? no problem.Was there another catheter inserted into the heart when the patient injury occur? farawave in the left atrium.Was a resistance able to be felt when this device was operated/removed? no mention was made of any resistance.Note: for any patient information field(s) left blank in the cnf - 'asked but not available as per account.' in addition, the e-mail address of the physician, who was also the initial reporter, was not available.Physician comments: patient outcome: no information available infected: no generator/controller: ablation catheter used: other used: event date: (b)(6) 2026.
Additional Manufacturer Narrative
No device was returned for analysis.Additional information provided on the 26th of august: ai: (b)(6) - correct information.Ai: (b)(6); patient outcome - deceased.Ai: (b)(6) - details of event.Please specify the patient's condition as well as the treatment provided (including whether any surgical intervention was performed, etc.) from the time of drainage until death.No surgical intervention was performed; bleeding could not be stopped despite drainage.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.Review of the failure matrix analysis rsk-dfmea-000049 rev.14 was carried out and this had indicated that the risk was included, and the current controls were sufficient.The current rating for the failure mode in question is 6 parts per million.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: 50514825
• Report Number: 9681477-2026-00110
• Device Sequence Number: 21501517
• Product Code: DQX
• UDI-Device Identifier: 08714729326731
• UDI-Public: (01)08714729326731(17)281111(10)10019443
• 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): 08/30/2026

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: 10019443
• 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: 08/10/2026
• Initial Report FDA Received Date: 08/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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: Death
• Patient Sex: Unknown