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

Model Number	H74939407XS0
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not received for evaluation at the time of this report; therefore, no visual or physical 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: never advance the guidewire against the 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should be taken when advancing the guidewire after device deployment.The wire should only be introduced into or withdrawn from the ventricle through a catheter already positioned into the ventricle.The curve of the safari2tm guidewire should be constrained within a catheter during insertion into or withdrawal from the body or treatment site.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.8.Confirm safari2tm guidewire curve position to assure safari2tm 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 safari2tm guidewire prior to withdrawing the wire.B.The safari2tm guidewire is pulled back completely into the catheter.C.The safari2tm 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.Based on the information provided, it appears that procedural and/or clinical factors may have impacted on the event as reported.Patient information was not provided.Sections in this report are blank or unknown due to missing information.Should additional information be received, a follow up medwatch report will be submitted.Note: although annex g instructions state that with stand-alone devices annex g term should not be used, code 4755 was selected due to component code (g) showing up on the missing data report.
Event or Problem Description
Event description: patient presenting with as admitted for tavi procedure.Femoral access: very narrow vessels, vasospasm suspected.Diameters did not match the ct scan from myself and center measurements.7fr sheath occluded distal flow.Covered stents prepared and safety wires placed in left femoral.Tavi procedure continued.Isleeve advanced with resistance but not abnormally so.Crossing annulus was extremely difficult and safari wire was very central even when placed deep in lv.Three cusp view checked, rc slightly high but did not correct, wanted to check with paralax.Pre-dil done with 20mm outflo balloon.No pacing.Safari wire seemed to correct position after this and sit flush against the outer curvature.Ds advanced to annular level.Commisural alignment was done.Advanced to bottom of annulus with only forwards movement.Initial position was very good, as seen on fluro, the safari had good position as well.During the deployment of the upper crown, the valve moved ventricular.There was a lot of resistance to retract it.I suggested moving to overlap to check in the upper crown was caught under the leaflet.At that point the patient was extremely unstable and needed cpr started asap.Hcp decided to release knob 1 and 2 in quick succession due to this.Knob 1 was released with lots of backwards tension, knob 2 was released slowly and not to hard stop (inexperienced operator).Operator 2 also first turned the handle in the opposite direction and then corrected.I am unsure of if it moved during this as i had already done pretension.After the knob 2 was deployed to hard stop, the nose cone did move forward but the capsule moved up.I was not sure if it was hooked but the hcp said he could not advance or retract the safari wire.The team did less than a minute of compressions and the patient stabilised.He tried to manipulation the ds a bit with the safari wire and eventually the system was able to be retracted.He said after that he believes the safari was hooked onto the nose cone of the ds and when we removed the safari, you could see the wire was damaged.We replaced the safari with another xs to do the post-dil.The valve looked very under expanded initially, it did slowly get better but in the rao view, it was narrowed at the outflow so we did post-dilate with 20mm outflo balloon.Good gradient and no leak.Echo done after due to damaged safari, no effusion apparent.Temp lead was placed due patient remaining in hard block.She will be admitted for (pp) within the week.What troubleshooting steps, if any, resolved the issue? manipulation of the safari wire and ds.What is the next course of action? complaint filed.No credit requested.Patient present at time of event? yes patient complications: other provide details for "other" patient complication: the patient needed to have a temp pacemaker put in.It is unclear if this was due to the prolonged ds interaction at annular level or the post-dilation.Permanent pacemaker expected.In the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes please describe the way in which the device or procedure caused or contributed to the patient complication?: the safari wire was damaged and we believe that caused the acurate ds to be stuck after deployment.The interaction of the ds at the annular level caused a lot of instability on the patient.Medical or surgical interventions: none, manipulation eventually released the system.Patient outcome: expected to fully recover.Question: was issue present upon opening package? answer: no question: any resistance encountered during advancement through anatomy? answer: yes, due to vaso spasm question: how far into the patient anatomy was the device able to be advanced? answer: full question: how was the procedure completed - were any devices exchanged (if yes, please specify)? answer: damaged safari xs replaced with new safari xs question: what were possible contributing factors (comorbidities, anatomy characteristics, etc)? answer: none question: where specifically on the device did the kink/bend occur? answer: on the safari curvature question: when specifically during device prep or during the procedure did the kink/bend occur? answer: not sure, could have been during bav, valve deployment.Question: is it known what caused the device to kink/bend? answer: no, could have been the bav or the knob 2 deployment question: where in the patient anatomy was the difficulty encountered? answer: at annular level question: was there a device interaction with another device? if yes, please explain and provide other product details: answer: yes, safari was being used to place tavi question: was any device damage noted? if yes, please specify where.Answer: yes, on the safari wire, the coils at the curvature.12may2025: question: when did the vasospasm occur/which devices were in use at the time: answer: no, was during initial access with 7fr sheath.The hcp now believes that the femoral kinked when anything was inserted and that is what caused the lack of flow.No vasospasm.Question: was the isleeve in place? answer: no question: was it during advancement of the safari? answer: before question: was it during advancement of the ds? answer: before question: you noted that after upper crown deployment the patient became unstable and required cpr.Can you expand on how specifically the patient was unstable? answer: the pressures dropped and it was decided to start compression as soon as they could.Question: can you provide a patient status update: was a permanent placer implanted? answer: no, patient stabilised with no conduction issues later that afternoon (heart block resolved).Patient currently in a-fib (hcp says it's unlikely related to the procedure), will go for cardioversion today and will be discharged by wednesday question: has the patient been discharged? answer: not yet 14may2025: question: listing and model of all other devices used during the procedure, include the model, brand name, sizes, etc.Answer: 7fr sheath, covered stents, 14f isleeve introducer sheath, 20mm outflo bav, medium acurate neo2 valve, acurate neo2 tf ds question: was bav successfully completed over the safari2 wire? answer: predil bav was successfully completed.The post dil was completed using a new safari wire.Question: was bav catheter removed successfully over the safari2 wire? answer: yes for predil.Yes, also with the new wire for post dil.Question: if the bav catheter was removed over the safari2 wire was there any resistance felt at any point? answer: no resistance, for predil with original wire nor for post dil with new wire.Question: please specify, what guidewire damage was found on the coils at the curvature (kink, bend, offsets, stretched coil wraps, etc.) answer: the coils looked stretched.I couldn't see a bend.Question: is there an image of the wire available? answer: unfortunately i was scrubbed and couldn't take pictures.Question: did the wire damage occur during cpr? answer: not sure, the time of damage is not certain as damage was noted upon removal.Question: was the curve of the safari2 guidewire constrained within a catheter during insertion into and withdrawal from the body or treatment site? answer: yes, the safari was placed in the lv using a pigtail as per guidelines.Question: did the end user advance the safari2 guidewire through the catheter under fluoroscopic guidance? answer: no, but it was placed in the lv and removed under fluro question: was visualization of the guidewire maintained during deployment? answer: yes question: patients condition following the procedure.If possible- provide the surgical/op report.Answer: report not available, but confirmed patient has been discharged.Question: patient age, weight, gender? answer: asked, not available.
Additional Manufacturer Narrative
This medwatch report is an update to the previous report to include additional information (b5), device evaluation ( h11) and to update the codes in h6 (b), (c), and (d).As received, the specimen consisted of one-1 each pkg-safari2 275cm xsml crv 1p; returned coiled, loose, and double-bagged within "zip-lock" style poly biohazard pouches.Note, the dispenser assembly was not returned with the specimen.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 coil offset/misaligned coil wraps throughout the formed curve distal region.The specimen also presented bend damage at 15 cm, 24 cm, 149.5 cm, and 161 cm from the distal aspect of the formed curve along with coil offset/misaligned coil wraps at 158.5 cm and 161cm.The specimen also presented stretched coil damage at 15cm from the distal aspect of the formed curve.The nature of the damage appeared consistent with manipulation of the wire against resistance, including torquing the wire.The distorted formed curve was likely due to the attempts to remove the specimen wire from the delivery system.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 indicated in the device instructions for use warnings: ·do not torque this guidewire.·never advance the guidewire against the 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 into the ventricle.·the curve of the safari2tm guidewire should be constrained within a catheter during insertion into or withdrawal from the body or treatment site.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.8.Confirm safari2tm guidewire curve position to assure safari2tm 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 safari2tm guidewire prior to withdrawing the wire.B.The safari2tm guidewire is pulled back completely into the catheter.C.The safari2tm 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.Based on the information provided and the evidence presented, it appeared that procedural and/or clinical factors have contributed to the event as reported.Should additional information be received, a follow up medwatch report will be submitted.
Event or Problem Description
Summary of the distributor's media review was received on 06jun2025: fluoroscopic procedural videos received indicate the following: aortogram showing coplanar alignment (lao 9 / cau 11) with mild aortic regurgitation.Left coronary angiography with no evidence of occlusive coronary artery disease.Crossing of the annular plane with a straight-tip guidewire.Attempted positioning of the j-tip guidewire in the left ventricle.Balloon aortic valvuloplasty.Advancement of the delivery system through the aortic annulus, noting resistance during the maneuver.Upper crown opened.Deployment sequence performed under significant traction on the system.Nose cone advances in the final sequence of deployment.Safari ii wire shows no signs of alterations in its configuration.Acurate prosthesis attached to the delivery system.Aortogram showing the acurate valve in the aortic position, slightly deeper in the ventricle than recommended.No visible signs of alterations in the safari ii wire structure.Patent coronary arteries.No evidence of aortic regurgitation or paravalvular leak.Post-dilation appears ineffective (does not seem to touch the limits of the valve stent and does not increase the diameter of the inflow or waste).Final aortogram showing the valve without signs of hypo-expansion, no aortic regurgitation, no signs of dissection or pericardial effusion, and patent coronary arteries.

• 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: 22055058
• Report Number: 2126666-2025-00025
• Device Sequence Number: 19896344
• Product Code: DQX
• UDI-Device Identifier: 08714729887638
• UDI-Public: (01)08714729887638(17)270730(10)9141218
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 06/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: H74939407XS0
• Device Catalogue Number: H74939407XS0
• Device Lot Number: 9141218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown