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

Model Number	H74939406XS0
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
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 noted in the device instructions for use , operational instructions: inspect and prepare the catheter according to the manufacturer's instructions.This includes flushing the catheter to be used with heparinized saline solution.Verify compatibility of interacting devices prior to use.As described in the device instructions for use, instructions for use: 1.Ensure a catheter is properly placed in the ventricle or other intended treatment area.2.Carefully remove the safari2 guidewire from the hoop by grasping the proximal end of the j-straightener separating the straightener from the hoop.3.After inspection of the safari2 guidewire, advance the j-straightener over the distal section of the safari2 guidewire to straighten the curve.4.Insert the safari2 guidewire into the hub of the catheter with the aid of the j-straightener.5.Carefully advance the distal tip of the safari2 guidewire into the lumen of the catheter.6.Remove the safari2 guidewire j-straightener by withdrawing it over the length of the safari2 guidewire.7.Advance 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.10.To remove the guidewire from the treatment area: a.A catheter must be advanced into the treatment area over the safari2 guidewire prior to withdrawing the wire.B.The safari2 guidewire is pulled back completely into the catheter.C.The safari2 guidewire may then be withdrawn from the catheter.As indicated in the device instructions for use warnings: never advance the guidewire against the resistance without first determining the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 into the ventricle.The curve of the safari2 guidewire should be constrained within a catheter during insertion into or withdrawal from the body or treatment site at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, procedural and/or clinical factors appear to have contributed to the event.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.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 to gather further details to obtain the information were made and no additional information was provided at the time of this report.Should additional information be received, a follow up medwatch report will be submitted.Note: although annex g instructions state that with stand-alone devices annex g term should not be used, code 4755 was selected due to component code (g) showing up on the missing data report.
Event or Problem Description
The navigator catheter with the mounted heart valve cannot be moved forwards or backwards on the guidewire before placement.What troubleshooting steps took place? pushed and pulled.What is the next course of action?: retracted.Patient present at time of event?: yes.Patient complications: no patient complications.Patient outcome: expected to fully recover.Additional information: question: was the physician ultimately able to retract the safari2 normally, or did the safari2 and valve system need to be removed together as a unit? answer: together as one unit.Question: do you know how far into the anatomy the valve system was when the issue occurred (e.G.At the level of the aortic valve)? answer: yes, at the height they wanted to implant.Question: was any damage observed to the safari2 prior to the procedure or after removal from the anatomy? answer: not prior the procedure, afterwards the competetor took everything.Question: please confirm the disposition of the safari2 wire.Was it disposed, or is it available for return? answer: the device was discarded at the facility and will not be returning.Question: how was the tavr completed? with a new safari2, different brand wire, etc.? answer: with a new safari2.Question: listing and model of other devices used during the procedure, include the model, brand name, sizes, etc.Answer: not available per account.Question: what valve size and which navigator catheter size were used? answer: valve size 24.5 mm x 30 mm/navigator catheter 16f.Question: was the navigator catheter flushed per ifu prior to advancing it over the wire? answer: yes.Question: was the initial valve used to complete the procedure? answer: yes.Question: was the curve of the safari2 guidewire constrained within a catheter during insertion into the body to the treatment site? answer: no.Question: was there any resistance noted during the initial placement of the safari2 guidewire into the treatment area? answer: no, only removal.Question: before resistance with the navigator occurred, was the delivery system advancing normally over the guidewire? answer: yes.Question: upon removal, did the wire show any deformation? if yes, please describe the damage and provide the specific location (e.G., distal curve, mid shaft, proximal shaft)? answer: at the beginning of the curve, so that it was not possible to retract.Question: was bav performed over the wire before introducing the valve system? if yes, was any resistance observed while advancing or withdrawing the bav catheter over the wire? answer: no.Question: are any photos of the wire available for review? answer: no.

• 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: 24445763
• Report Number: 2126666-2026-00009
• Device Sequence Number: 18717196
• Product Code: DQX
• UDI-Device Identifier: 08714729887621
• UDI-Public: (01)08714729887621(17)280408(10)973959
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K151244
• 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): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939406XS0
• Device Catalogue Number: H74939406XS0
• Device Lot Number: 9723959
• 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: 02/10/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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
• Patient Sex: Unknown