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

Model Number	H74939406XS0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/17/2025
Type of Reportable Event	Death
Event or Problem Description
Event description: the patient underwent a tavi procedure via the left subclavian artery due to severe aortic valve stenosis.During the procedure, the artery was punctured, and in the usual manner, an introducer sheath (medtronic) as well as a guidewire (boston scientific safari xs wire) were advanced through the artery, across the native stenotic valve, and into the left ventricle of the heart.The tavi valve (medtronic evolut fx+) was being deployed normally when the patient's blood pressure suddenly collapsed, and resuscitation was immediately initiated.The partially deployed tavi valve was withdrawn back into the delivery catheter.Bleeding into the pericardial space was identified, and pericardiocentesis was performed while resuscitation was ongoing.The bleeding continued, the situation did not stabilize during 25 minutes of resuscitation, and the patient was pronounced deceased.The clinical suspicion at the time of the event was that the outcome may have been associated with either a perforation of the left ventricle or injury to the aortic root.In the forensic determination of the cause of death, perforation of the left ventricle was identified.A definitive cause of the performation could not be established.The guidewire functioned normally prior to the complication, and no abnormalities were observed during its use.
Additional Manufacturer Narrative
The device involved in this event was not returned for evaluation and was reportedly disposed of; 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 as intended with no abnormalities observed during use.A definitive root cause cannot be established.The available information suggests that the event may be associated with clinical and/or procedural factors.Cardiac perforation 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.This report is submitted as a good faith effort to comply with mdr reporting requirements.The patient information was not provided; therefore part a could not be completed.The sections left blank or unknown on this form could not be completed due to missing information.Attempts were made to obtain additional details; however, no further information was provided.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: 25562984
• Report Number: 2126666-2026-00040
• Device Sequence Number: 10280819
• Product Code: DQX
• UDI-Device Identifier: 08714729887621
• UDI-Public: (01)08714729887621(17)280615(10)9928114
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 06/19/2026

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: H74939406XS0
• Device Catalogue Number: H74939406XS0
• Device Lot Number: 9928114
• 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: 05/29/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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