MAUDE Adverse Event Report: Solo Pace, Inc. Solo Pace Fusion System; Guidewire

Model Number	SOLOFUSE1
Medical Device Problem Code	Intermittent Capture (1080)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a follow-up interview with the user, it was determined that loss of capture occurred during the procedure.Review of the procedural imaging identified that the fusion wire was positioned on top of the mitral valve apparatus where loss of contact is a known risk during valve deployment when balloon inflation shifts the relationship of the conducting part of the lead wire to the myocardium and leads to loss of contact and resultant loss of capture.The epg was evaluated and found to be within specification for all requirements and testing did not identify any pacing or sensing issues.A review of the epg logs did not identify any pacing or sensing issues.A review of the production records did not identify an issue with the epg or fusion components.Based on the information obtained from the customer and review of the imaging, the valve embolization appears to be due to the position of the fusion wire, which resulted in loss of capture.
Event or Problem Description
Customer reports that the valve embolized while using solopace fusion.Valve that embolized required a stent to secure.Patient outcome was good.

• Brand Name: Solo Pace Fusion System
• Common Device Name: Guidewire
• Manufacturer (Section D): Solo Pace, Inc.; 7125 northland terrace n; brooklyn park MN 55428
• Manufacturer (Section G): Solo Pace; 7125 northland terr n; brooklyn park MN 55428
• Manufacturer Contact: straight ; 7125 northland terr n; brooklyn park, MN 55428 ; +1(612)940-7240
• MDR Report Key: 50951237
• Report Number: 3035372913-2026-00013
• Device Sequence Number: 13369407
• Product Code: DQX
• UDI-Device Identifier: 00850056280044
• UDI-Public: 00850056280044
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K252674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: SOLOFUSE1
• Device Lot Number: H3526763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown