MAUDE Adverse Event Report: LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI2; WIRE, GUIDE

Model Number	H74939406XS1
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: safari was not used because already while the physician took the wire out of the snail, he noticed that the wire was not covered and there was an 'edge.' what troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: n.A: what is the next course of action?: n.A: patient present at time of event?: no patient complications: no patient complications note: this medwatch report is being filed based on the images received along with the product evaluation.
Additional Manufacturer Narrative
This medwatch report is being filed based on the image received on april 28, 2023, and the product evaluation, both revealing a fracture of the core wire material.As received, the specimen consisted of one-1 each safari2 275cm xsml crv; returned reloaded into the dispenser assembly, lodged within the j-straightener and double-bagged within "zip-lock" style poly biohazard pouches.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 an unknown distance from the distal tip weld mass with concurrent stretched coil damage of 11.4cm, the distal tip is lodged within the lumen the j-straightener attachment 3.4 cm from the distal tip of the j-straightener along with the traces of dried blood.The information in the event description does not mention the safari2 guidewire being lodged within the j-straightener attachment or a fracture of the core wire; therefore, the exact timing of the damage cannot be determined at this time.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 preparation for use: safari2tm guidewires should be handled carefully and inspected before use and when possible, during the procedure to observe for any defect or damage that may occur.Do not use a wire that has a damaged coating, tip, camber (change in plane), bend or kink on the wire.Damage will hinder the performance of the safari2tm as described in the device instructions for use (dfu): ensure a catheter is properly placed in the ventricle or other intended treatment area.Carefully remove the safari2tm guidewire from the hoop by grasping the proximal end of the j-straightener separating the straightener from the hoop.Fter inspection of the safari2tm guidewire, advance the j-straightener over the distal section of the safari2tm guidewire to straighten the curve.Insert the safari2tm guidewire into the hub of the catheter with the aid of the j-straightener.Carefully advance the distal tip of the safari2tm guidewire into the lumen of the catheter.Remove the safari2tm guidewire j-straightener by withdrawing it over the length of the safari2tm guidewire.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 appeared that handling factors have contributed to the event as reported.No patient information was provided at the time of this report.If there is any further relevant information provided, a follow up medwatch report will be submitted.

• Brand Name: PREFORM GUIDEWIRE - 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: 16918940
• Report Number: 2126666-2023-00029
• Device Sequence Number: 15183508
• Product Code: DQX
• UDI-Device Identifier: 08714729887614
• UDI-Public: 08714729887614
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/12/2023

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: 09/25/2025
• Device Model Number: H74939406XS1
• Device Catalogue Number: 39406XS
• Device Lot Number: 7376187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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