MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VSI TEMPORARY PACING GUIDEWIRE, 1PK; CATHETER GUIDEWIRE

Catalog Number	2250
Medical Device Problem Code	Unstable Capture Threshold (3269)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "valve embolization during tavr procedure.Wattson wire was seemingly functioning properly during valve deployment.Loss of proper pacing was noted during the final moment of deployment, causing sudden movement of the heart, and the valve to be displaced backwards into the aorta.Embolized valve was drug backwards into the descending aorta and secured in place with a thoracic endograft.A new tavr valve was placed in the correct position.The patient did not experience any signs or symptoms due to this event.A temporary-permanent pacing lead was inserted and secured into the patient's rv to provide pacing during the second valve deployment.A new edwards tavr valve and delivery system was then placed through the graft and utilized to deploy a second tavr valve in the correct position across the aortic valve.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "valve embolization during tavr procedure.Wattson wire was seemingly functioning properly during valve deployment.Loss of proper pacing was noted during the final moment of deployment, causing sudden movement of the heart, and the valve to be displaced backwards into the aorta.Embolized valve was drug backwards into the descending aorta and secured in place with a thoracic endograft.A new tavr valve was placed in the correct position.The patient did not experience any signs or symptoms due to this event.A temporary-permanent pacing lead was inserted and secured into the patient's rv to provide pacing during the second valve deployment.A new edwards tavr valve and delivery system was then placed through the graft and utilized to deploy a second tavr valve in the correct position across the aortic valve.".
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of "loss of proper pacing" was able to be confirmed through review of the customer supplied video.The video shows the deployment of the valve.As the balloon is inflating, pacing appears consistent.At the end of the deployment, it appears that pacing is lost, and the balloon and valve embolize into the aorta.The customer returned one wattson wire, one adapter, and the device label for analysis.Visual analysis revealed one kink in the body of the wire, as well as one minor bend.No foreign material or excessive biological material was observed on the proximal electrodes.The wire and adapter were tested for continuity and resistance by r & d unit.The test was repeated a total of five times, and no issues were noted.The parts functioned as intended.Additional information indicated that the patient's current condition is fine.Additionally, as per the customer, it was stated that multiple potential issues may have contributed to the event including the electrical conductivity of the patient's heart tissue after a recent myocardial infarction, insufficient electrical threshold testing, initial positioning of the valve, valve deployment time, and the depth of the wattson wire within the left ventricle.A device history record review was performed, and no relevant findings w ere identified.Based on the customer report and the sample received, no product malfunction was identified.

• Brand Name: VSI TEMPORARY PACING GUIDEWIRE, 1PK
• Common Device Name: CATHETER GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23973049
• Report Number: 2134812-2026-00001
• Device Sequence Number: 9295626
• Product Code: DQY
• UDI-Device Identifier: 10841156106492
• UDI-Public: (01)10841156106492(11)240917(17)260917(10)47E2400549(21)
• Combination Product (Y/N): N
• PMA/510(K) Number: K192454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 09/17/2026
• Device Catalogue Number: 2250
• Device Lot Number: 47E2400549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown