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

Model Number	H74939406S1
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: it was reported that: acurate neo delivery system was stuck on the safari2 guidewire during implantation.As a result the valve was implanted successfully and the ds removed together with safari guidewire.Before the procedure hcp formed additionally the guidewire.Device could not be returned because of the local regulatory restrictions.Did any patient harm occur? no.Was bav performed? yes.Associated with labeled use? yes.Action taken to resolve: none.Patient status post procedure/event: no notable comlications.Patient complications: none.When did event occur? during valve implantation.After deployment of the proximal filter, was there difficulty maneuvering and positioning the articulating sheath? no.Was there difficulty advancing the distal filter #3 hub forward? yes.Did the distal filter fully expand and appose to the vessel wall? no.
Additional Manufacturer Narrative
Product is not being returned; therefore, no physical or visual analysis 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 indicated in the device instructions for use warnings: monitor wire position throughout the procedure for proper placement of the curve and distal tip.When advancing or removing the guidewire, always use fluoroscopic guidance with radiographic equipment that provides high-resolution images.Never position the guidewire blindly, as this may result in misplacement, dissection or perforation.Never advance the guidewire against resistance without first determining the reason for resistance.The curve of the safari2 guidewire should be constrained within a catheter during insertion into or withdrawal from the body or treatment site.As indicated in the dfu, operational instructions, instructions for use: 7.Advance safari2 guidewire through the catheter under fluoroscopic guidance.8.Confirm safari2 guidewire curve position to assure safari2 guidewire placement and stability.9.Maintain wire position while tracking or advancing a catheter or device over the wire.10.To remove the guidewire from the treatment area: a.A catheter must be advanced into the treatment area over the safari2 guidewire prior to withdrawing the wire.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 procedural and/or clinical factors impacted on the event as reported.The patient information was not provided at the time of this report.If there is any further relevant information received, 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: 16259426
• Report Number: 2126666-2023-00006
• Device Sequence Number: 4779159
• Product Code: DQX
• UDI-Device Identifier: 08714729887591
• UDI-Public: 08714729887591
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 01/27/2023

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: 08/08/2024
• Device Model Number: H74939406S1
• Device Catalogue Number: 39406S
• Device Lot Number: 6550686
• 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: 01/12/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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