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

Model Number SAFARI2 - UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

Product was reported to have been disposed; therefore, no physical or visual analysis of the product could be performed.The lack of lot traceability prevents performing a device history records review for any indication of manufacturing defect or anomaly that could have impacted on the event as reported.A review of the manufacturing processes indicates the production operators are instructed to 100% visually inspect for any obvious defect prior to shipment.As indicated in the device instructions for use (dfu) warnings section: 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 under fluoroscopy.Excessive force against resistance may result in damage to the catheter or vessel/organ.Care should be taken when advancing the guidewire after device deployment.The wire should only be introduced into or withdrawn from the ventricle through a catheter already positioned in the ventricle.The curve of the safari2 guidewire should be constrained with in a catheter during insertion into or withdrawal from the body or treatment site.As indicated in the device instructions for use: 1.Ensure a catheter is appropriately placed in the ventricle or other intended treatment area.2.Carefully remove the safari2 guidewire, from the hoop by grasping the proximal end of the j-straightener separating the straightener from the hoop.3.After inspection of the safari2 guidewire, advance the j-straightener over the distal section of the safari2 wire to straighten the curve.4.Insert the safari2 guidewire into the hub of the catheter with the aid of the j- straightener.5.Carefully advance the distal tip of the safari2 guidewire into the lumen of the catheter.6.Remove the safari2 guidewire j- straightener by withdrawing it over the length of the safari2 guidewire.7.Advanced the 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.B.The safari2 guidewire is pulled back completely into the catheter.C.The safari2 guidewire may then be withdrawn from the catheter.At this time, it is not possible to assign a definitive root cause for the event as reported.At the time of this report there is no known relationship between the safari2 guidewire and the adverse event; therefore, this medwatch report is being filed as a good faith measure.If any further relevant information is received, a follow up medwatch report will be submitted.

Event Description

The femoral access and insertion of the isleeve were done without any complications.The physicians noticed some difficulty and resistance in advancing the pigtail into the aortic arch and decided to puncture the left femoral instead of the left radial artery.The acurate neo2 aortic valve m was loaded.Both the delivery system and valve looked as they should.It was not difficult to attach the hooks and pins.The rep showed it to one of the loading nurses and together they checked the hooks and pins several times.They thought it was easy to identify each pin and that they were well attached.All the loading steps were performed according to the manufacturer's guidelines and nothing unusual was detected.After that, they proceeded to a pre-dilation of the native aortic valve with a 22 mm true¿ dilatation balloon.The rep applied pre-tension in the system before handling the same to the second operator.Normal procedure until insertion of the valve in the patient.The acurate neo2 tf delivery system was being advanced into position, and when the acurate neo2 tf delivery system was in the ascending aorta level, it was noted that the acurate neo2 aortic valve was misloaded.The patient was doing badly (bp around 50/30mmhg) and started to lose consciousness doing to the interaction of the guidewire with the mitral apparatus and/or the occlusion in the aorta with the delivery system, which demanded a quick action, and the physicians deployed the valve by opening knob 1 under rapid pacing (180bpm).The valve was deployed in the right position with no complications.The patient will be discharged as the plan - on the day after.What troubleshooting steps, if any, resolved the issue?: rapid pacing during knob 1 what is the next course of action?: the patient will be sent home on the following day, as usual.Patient present at time of event?: yes.Patient complications: no patient complications.The safari wire was totally fine.Sometimes it can be malpositioned and get entangled in the mitral chordae, and that is easily corrected by moving it inside a catheter, the balloon, or even inside the delivery system itself.If it interacts with the mitral valve, can cause a bigger mitral leakage and a drop in the blood pressure.Additional information received from the distributor, "we have not received confirmation if the guidewire entanglement with the mitral valve apparatus was confirmed or was only a supposition as to why the patient became hypotensive and lost consciousness.".

• Brand Name: PREFORM GUIDEWIRE-SAFARI2
• Type of Device: 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: 16709559
• MDR Text Key: 313011429
• Report Number: 2126666-2023-00024
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K151244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAFARI2 - UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female