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

Model Number	H74939706JPNS0
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	07/09/2024
Type of Reportable Event	Death
Event or Problem Description
Event description: a transcatheter aortic valve implantation was performed and a 25 mm navitor transcatheter bioprosthetic valve system was attempted.During the implantation of the navitor, the blood pressure decreased and an echocardiogram was performed, which revealed a pericardial effusion.The physician determined that the use of the safari guidewire had caused left ventricular perforation, leading to cardiac tamponade.Pericardial drainage was performed, and the patient immediately underwent open-chest surgery.Hemostasis was attempted at the perforation site by suturing, but as this was not achieved, left ventricular reconstruction was performed.However, as the bleeding was still not completely stopped, the patient was returned to the intensive care unit (icu) with some degree of hemostasis achieved.On (b)(6) 2024, the patient died.Regarding the cause of death, the physician stated that the cause of death was hemorrhage due to perforation of the left ventricular apex by a guidewire.
Additional Manufacturer Narrative
Product was discarded; therefore, no visual or physical analysis of the product could be performed.A review of the device history records of the specimen device does 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.As indicated in the device instructions for use (dfu) warnings section: ·monitor wire position throughout the procedure for proper placement of the curve and distal tip.·when advancing or removing the guidewire, always use fluoroscopic guidance with radiographic equipment that provides high-resolution images.Never position the guidewire blindly, as this may result in misplacement, dissection or perforation.·never advance the guidewire against resistance without first determining the reason for resistance under fluoroscopy.Excessive force against resistance may result in damage to the catheter or vessel/organ.Care should be taken when advancing the guidewire after device deployment.·the wire should only be introduced into or withdrawn from the ventricle through a catheter already positioned in the ventricle.·the curve of the safari2 guidewire should be constrained with in a catheter during insertion into or withdrawal from the body or treatment site.As indicated in the device instructions for use: 7.Advanced the safari2 guidewire through the catheter under fluoroscopic guidance.8.Confirm safari2 guidewire curve position to assure safari2 guidewire placement and stability.9.Maintain wire position while tracking or advancing a catheter or device over the wire.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided to date, it appears that clinical and/or procedural factors have contributed to the event.Although the exact cause of the perforation has not been determined, cardiac perforation, tamponade, pericardial effusion, and death are known potential adverse events and are listed in the safari2 instructions for use (ifu).The sections left blank or unknown on this form could not be completed due to missing information.An attempt to gather further details to obtain the information was made; however, per the distributor, good faith efforts have been performed and at the time of this report no additional information has been received regarding this event.Should additional information be received, a follow up medwatch report will be submitted.

• 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 55318 ; 9526418518
• MDR Report Key: 19933575
• Report Number: 2126666-2024-00056
• Device Sequence Number: 11474689
• Product Code: DQX
• UDI-Device Identifier: 00816349012327
• UDI-Public: (01)00816349012327(17)261030(10)8302896
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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: H74939706JPNS0
• Device Catalogue Number: H74939706JPNS0
• Device Lot Number: 8302896
• 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: 07/30/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• 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: 50 KG