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

Model Number	H74939406XS0
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: the issue became when trying to retract the wire through the edwards valve delivery system.The wire became hard to retract and the tip unraveled.What troubleshooting steps, if any, resolved the issue? had to put very hard to get the wire to come out.Patient present at time of event? yes.Patient complications: no patient complications.Patient outcome: fully recovered.Procedure date: unknown.Was issue present upon opening package? no.Procedure outcome: original method/device used.Question: any resistance encountered during advancement through anatomy? answer: no.Question: how was the procedure completed - were any devices exchanged (if yes, please specify)? answer: no.Question: where in the patient anatomy was the difficulty encountered? answer: unknown.Question: was there a device interaction with another device? if yes, please explain and provide other product details: answer: edwards delivery system.Question: was any device damage noted? if yes, please specify where.Answer: tip of wire.
Additional Manufacturer Narrative
Product was not received for evaluation at the time of this report; therefore, no physical analysis of the product could be performed.This report is being filed based on the evaluation of the image provided on (b)(6) 2025, which revealed a fracture to the core wire material.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.The image provided shows a safari2 guidewire, including the j-straightener.The guidewire's core material exhibits fracture/shear damage at an unspecified distance from the distal tip.Additionally, the surrounding coil material appears stretched, suggesting possible tensile stress or deformation during use.As indicated in the device instructions for use warnings: exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking or coil separation.Resulting guidewire fractures might require additional percutaneous intervention or surgery.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 a 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 within a catheter during insertion into or withdrawal from the body or treatment site.As described in the device instructions for use preparation for use: 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.If coils of a guidewire separate, do not remove the core.Carefully remove the coils and core simultaneously.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided and the evidence presented, it appeared that procedural and/or handling factors have contributed to the event as reported.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 patient information and event date were not provided.Therefore, part a and part b (3) 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 additional information were made and no additional information was provided regarding this event 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 due to component code (g) showing up on the missing data report.

• 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: 23830460
• Report Number: 2126666-2025-00049
• Device Sequence Number: 15772425
• Product Code: DQX
• UDI-Device Identifier: 08714729887621
• UDI-Public: (01)08714729887621(17)280922(10)10094811
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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): 12/17/2025

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: 10094811
• 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: 12/02/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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