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

Model Number	H74939407XS0
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is being filed based on the image received on february 28, 2024, which presented a core wire fracture.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 28.2 cm.The distal tip is lodged within the lumen of the j-straightener attachment 3.6 cm from the distal tip of the j-straightener along with traces of dried blood.The specimen also presented coil misalignment at 2.2 cm and 3.0 cm from the proximal aspect of the formed curve along with kink/bend damage in the small 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 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 and the evidence presented, it appeared that handling factors have contributed to the event as reported.Patient information is unknown.If there is any further relevant information provided, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: safari wire was taken out of the package to use during a tavi procedure.When using the j-straightener that is used to aid in the insertion of the guidewire into the delivery catheter, they were unable to advance the guidewire into the delivery catheter through the j-straightener.The guidewire was stuck and when they tried to retrieve the guidewire, the guidewire uncoiled the guidewire went not into the patient, just the j-straightener touched the pigtail and that's why some blood is into the straightener.What troubleshooting steps, if any, resolved the issue?: another guidewire was taken.What is the next course of action?: a new guidewire used without any issue.Patient present at time of event?: yes.Patient complications: no patient complications.
Additional Manufacturer Narrative
Correction to a previously submitted mdr to correct the brand name in section d1 and the 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: 18827714
• Report Number: 2126666-2024-00018
• Device Sequence Number: 3076088
• Product Code: DQX
• UDI-Device Identifier: 08714729887638
• UDI-Public: (01)08714729887638(17)260821(10)8156749
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 06/24/2024

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: 08/21/2026
• Device Model Number: H74939407XS0
• Device Catalogue Number: H74939407XS0
• Device Lot Number: 8156749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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