MAUDE Adverse Event Report: LAKE REGION MEDICAL SAFARI2¿; WIRE, GUIDE

Model Number	H74939706JPNXS0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	05/12/2026
Type of Reportable Event	Death
Event or Problem Description
A patient with severe aortic valve stenosis underwent a tavi procedure.During advancement of the navitor transcatheter heart valve system with flexnav delivery system across the aortic valve, st-segment elevation, hypotension, and circumferential pericardial effusion were observed.Pericardiocentesis was performed, and bloody pericardial drainage was confirmed.Ecmo was subsequently initiated.The physician diagnosed cardiac tamponade.An emergency thoracotomy was performed and revealed a left ventricular apex perforation.Left ventricular repair was performed, and hemostasis was achieved.The procedure was completed without valve implantation.The patient died the same day, with the cause of death reported as left ventricular perforation.The physician's opinion was that the perforation was caused by the safari2 guidewire used during the procedure.Additional information indicated that the guidewire functioned normally with no reported malfunctions.The procedure was complicated by severe aortic tortuosity and significant calcification of the aortic valve leaflets, which made advancement of the tavi delivery system more difficult than usual.A long sheath was used to address the aortic tortuosity.It was further noted that guidewire manipulation may have been affected by the patient's anatomy.
Additional Manufacturer Narrative
The device involved in this event was reported as not available to be returned for evaluation; therefore, no visual or physical examination could be performed.A review of the device history records for the subject device did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Based on available information, no device malfunction was identified.The guidewire was reported to have functioned normally with no reported malfunctions during the procedure.A definitive root cause cannot be established.The available information suggests that the event is associated with clinical and/or procedural factors.Cardiac perforation, pericardial effusion, tamponade, and death are known potential adverse events and are listed in the safari2 ifu.We reviewed the associated risk documentation relative to this product and confirmed that this incident is listed and that it is trending within the established occurrence threshold.Lake region's effectiveness of design verification activities brings the overall risk down to as far as possible.The sections left blank or unknown on this form could not be completed due to missing information.Multiple attempts were made to obtain additional details; however, no further information was provided at the time of this report.Should additional information be received, a follow-up medwatch report will be submitted.Although annex g instructions state that with stand-alone devices annex g term should not be used, code 4755 was selected because the system requires a value in h6(g).

• Brand Name: SAFARI2¿
• Common Device Name: WIRE, GUIDE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: sharon seifert ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418518
• MDR Report Key: 25635584
• Report Number: 2126666-2026-00041
• Device Sequence Number: 9561980
• Product Code: DQX
• UDI-Device Identifier: 00816349012334
• UDI-Public: (01)00816349012334(17)290202(10)10424424
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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: H74939706JPNXS0
• Device Catalogue Number: H74939706JPNXS0
• Device Lot Number: 10424424
• 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: 06/11/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2026
• 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: Death
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 44 KG