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

Model Number	H74939407S0
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure the safari guide is stuck in the guide pass after several attempts we removed the guide in the condition as in the photo.The procedure was completed using a different device (same model).No reported consequence or impact to the patient.
Additional Manufacturer Narrative
This medwatch report is being filed based on the image received on (b)(6) 2024.The supplied image presented a ductile, tensile overload fracture of the core wire at an unknown distance from the distal tip with subsequent coil stretching.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 described in the device instructions for use (dfu) 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.As described in the device instructions for use (dfu): 1.Ensure a catheter is properly placed in the ventricle or other intended treatment area.2.Carefully remove the safari2tm guidewire from the hoop by grasping the proximal end of the j-straightener separating the straightener from the hoop.3.After inspection of the safari2tm guidewire, advance the j-straightener over the distal section of the safari2tm guidewire to straighten the curve.4.Insert the safari2tm guidewire into the hub of the catheter with the aid of the j-straightener.5.Carefully advance the distal tip of the safari2tm guidewire into the lumen of the catheter.6.Remove the safari2tm guidewire j-straightener by withdrawing it over the length of the safari2tm guidewire.7.Advance the safari2tm guidewire through the catheter under fluoroscopic guidance.As described in the device instructions for use (dfu) warnings: ·exercise care in handling of the guidewire during a procedure to reduce the possibility if accidental breakage, bending, kinking or coil separation.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.An attempt to gather further details was made; however, at the time of this report no further information has been received regarding this event.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.

• 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: 20885251
• Report Number: 2126666-2024-00080
• Device Sequence Number: 8839849
• Product Code: DQX
• UDI-Device Identifier: 08714729887652
• UDI-Public: (01)08714729887652(17)260730(10)7860190
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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 Expiration Date: 07/30/2026
• Device Model Number: H74939407S0
• Device Catalogue Number: H74939407S0
• Device Lot Number: 7860190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 75 KG