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

Model Number	H74939706JPNXS0
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is being filed based on images received from the distributor on march 7, 2024, revealing fractured material.As received, the specimen consisted of one-1 each pkg-safari2 jpn 275cm x sml 5p; returned coiled, loose, and double-bagged within "zip-lock" style poly biohazard pouches.Note, the distal tip was lodged within the j-straightener.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 images supplied by the distributor presented a fracture of the core wire and stretched coil wraps in the distal tip extending proximally from the j-straightener with the distal tip lodged within the j-straightener.Te returned specimen presented a ductile, tensile overload of the core wire an unknown distance from the distal tip weld mass with concurrent stretched coil damage of 3.1cm, the distal tip is lodged within the lumen of the j-straightener attachment 3.6cm from the distal tip of the j-straightener.The specimen also presented an approximate length of 4.0cm of exposed core wire at the proximal aspect of the core wire fracture.The specimen also presented kink / bend damage approximately 153.2cm from the formed distal curve.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 indicated in the dfu, 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 and the evidence presented, it appeared that handling factors have contributed to the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: per cnf, it was reported that: event others (please specify the details in the event description column.) shaping: no said that the tip was deformed.Physician comments: patient outcome: no patient injury infected? unknown tortuosity of anatomy? unknown percentage of stenosis? unknown lesion calcification? unknown introducer sheath used: unknown guidewire used: unknown guide catheter used: unknown balloon catheter used: unknown stent used: unknown inflation device used: unknown imaging catheter: unknown 26 february 2024- distributor provided the following statement in response to attempts to gather further event information: according to sales representative, it is not able to obtain details about this case since entry to the hospital is currently controlled due to covid-19.For this reason, no further information is available.7 march 2024- received notification of product return along with images.Based on the images, the event was determined to be reportable.
Additional Manufacturer Narrative
This medwatch report is an update to the previous report to correct the brand name in section d1 and the model number, catalog number and primary unique device identifier (udi) number in section d4.

• 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: 18920775
• Report Number: 2126666-2024-00019
• Device Sequence Number: 15003038
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: H74939706JPNXS0
• Device Catalogue Number: H74939706JPNXS0
• Device Lot Number: 8156741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 06/27/2024
• 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