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

Model Number	H74939706JPNXS1
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is being filed based on the evaluation of the product return, which was received on november 22, 2024.The product received presented a tensile overload of the core wire.As received, the specimen consisted of one-1 each pkg-safari2 jpn 275cm x sml 5p; returned reloaded into the dispenser assembly; double bagged within "zip-lock" style poly biohazard pouch.Note: the j-straightener was not returned with the specimen.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 specimen presented a ductile, tensile overload of the core wire at 0.1cm from the distal tip weld mass with approximately 4.8cm of concurrent stretched coil damage beginning at the distal tip.The specimen presented bend damage in the small diameter curve.The specimen presented coil damage at 2.3cm and kink damage at 12.1cm from the distal aspect of the formed curve.There was no mention of the tensile/shear overload of the core wire material in the event description; therefore, the exact timing cannot be confirmed.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.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.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appears that handling factors have contributed to the event as reported.The patient information was requested and reported as not available.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.
Event or Problem Description
Event description: it was reported that the inserter could not be removed, and the wire was damaged when pulled with strong force.The location of the damage was unknown.Was there any appearance abnormality before use? no.Resolution: completed with another of same device.Where did event occur: outside the patient.Where did event occur: no patient injury.

• 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: 20800218
• Report Number: 2126666-2024-00079
• Device Sequence Number: 7980685
• Product Code: DQX
• UDI-Device Identifier: 00816349012334
• UDI-Public: (01)00816349012334(17)260806(10)8156741
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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: 08/06/2026
• Device Model Number: H74939706JPNXS1
• Device Catalogue Number: H74939706JPNXS1
• Device Lot Number: 8156741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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 Sex: Unknown