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	Perforation (2001); Pericardial Effusion (3271)
Date of Event	03/02/2026
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.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
Event description: ecn event description: during the procedure, the physician performed the first transseptal, crossed with the wire, and decided to perform a second transseptal.The physician exchanged for the catheter and began ablating when noticing a drop in pressure and effusion.The ablation was completed and the removed from the la as a pericardiocentesis was prepped and performed.Patient present at time of event?: yes patient complications: pericardial effusion in the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes please describe the way in which the device or procedure caused or contributed to the patient complication?: a perforation likely occurred during transseptal or during the ablation medical or surgical interventions: pericardiocentesis patient admitted to hospital beyond the standard of care: yes patient discharged from hospital?: no patient outcome: the issue is ongoing procedure number: pn-3059043 event date: 2026-3-2 as reported device codes: 2099: no known device problem as reported patient codes: 9221: pericardial effusion, 9213: perforation country of event: united states returned product expected: no related product upn #: m001491561 related product batch/lot: 0010019319 related product family: starter.Material number: m001491561.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross, co. wexford Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross, co. wexford Y34 K 825; EI Y34 K825
• Manufacturer Contact: suzanne foley ; butlersland; new ross, co. wexford Y34 K-825 ; EI Y34 K825
• MDR Report Key: 24601548
• Report Number: 9681477-2026-00037
• Device Sequence Number: 20928903
• Product Code: DQX
• UDI-Device Identifier: 08714729326731
• UDI-Public: (01)08714729326731(17)281005(10)10019319
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 03/15/2026

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: 10019319
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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