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)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: the wire could not be advanced out of the plastic protective housing, nor could it be pulled back.When forcefully pulled back, it unraveled.What troubleshooting steps, if any, resolved the issue?: none, new wire taken patient present at time of event?: yes.Patient complications: no patient complications.Was issue present upon opening package?: no.Question: how was the procedure completed - were any devices exchanged (if yes, please specify)? answer: took a new wire, no.Question: what were possible contributing factors (comorbidities, anatomy characteristics, etc)? answer: none.Question: was any device damage noted? if yes, please specify where.Answer: yes, device damaged trying to remove from packaging question: what was the suspected cause of the reported event? answer: not sure.
Additional Manufacturer Narrative
This medwatch report is being filed based on images received from the distributor on august 23, 2024, which appear to present fractured material.The device was not returned for evaluation at the time of this report; therefore, no physical evaluation of the product could be performed.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): 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.The images received from the distributor consisted of a series of five images.Three of the five images present the wire within the j-straightener with stretched coil wraps.Two of the five images present the j-straightener removed from the safari2 guidewire, and one of the two images presents the distal end of the safari2 guidewire and what appears to be stretched coil wraps and a fracture of the core wire material.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.The patient information was requested and reported as not available.The sections left blank or unknown on this form could not be completed due to missing information.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.

• 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: 20182597
• Report Number: 2126666-2024-00062
• Device Sequence Number: 15686090
• Product Code: DQX
• UDI-Device Identifier: 08714729887621
• UDI-Public: (01)08714729887621(17)260219(10)7595099
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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: 02/19/2026
• Device Model Number: H74939406XS0
• Device Catalogue Number: H74939406XS0
• Device Lot Number: 7595099
• 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: 08/23/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2023
• 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