MAUDE Adverse Event Report: OPSENS SAVVYWIRE; PRE-SHAPED PRESSURE GUIDEWIRE

Model Number	X-SMALL
Medical Device Problem Codes	Capturing Problem (2891); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/07/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The savvywire was discarded and not returned to the manufacturer.No inspection was possible.No imaging and no additional data were provided by the account as of april 4th, 2025.Check of the device history records (dhr) of guidewire lot number osw-0323 showed that it was released per specifications.Based on the available information, pacing test was performed before valve deployment, as prescribed, confirming ventricular capture and thresholds.Without inspecting the wire, opsens is not able to fully investigate therefore no definitive root cause can be concluded in this report.If there is any further relevant information, a follow up report will be submitted to the fda.The adverse event result of this incident is well mentioned in the savvywire instructions of use (ifu): adverse events that may result from the use of this device include, but are not limited to: access site or vessels complications, additional surgical procedure, allergic reactions, amputation, aneurysm, angina, arrhythmia, bleeding, cardiac or vessel perforation/dissection, coronary obstruction, death, embolism, fibrillation, foreign body/wire fracture, heart block, hematoma, hypotension/hypertension, infection, kidney injury/failure, myocardial infarction, need for permanent pacemaker, pericardial effusion, pneumothorax, stroke or other neurologic event, spasm, tamponade, thrombus, valve dysfunction or complications, valve malpositioning or embolization, vasospasm, vessel occlusion, wire entrapment/entanglement, x-ray radiation exposure complications.
Event or Problem Description
Event as described by opsens sales representative: procedure type: tavr.Valve: edwards sapien 26mm.Loss of capture during deployment of the valve.The edwards valve embolized.Intervention was performed to move the valve to an appropriate area in the aorta.The patient did not survive despite their efforts.Pacing rate 180, output of 20ma.Voo was confirmed.Before the deployment of the valve test pacing was conducted.Pacing rate of 120, output of 20ma walked down until loss of capture at 10ma.

• Brand Name: SAVVYWIRE
• Common Device Name: PRE-SHAPED PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750 blvd du parc technologique; québec, québec G1P4S 3; CA G1P4S3
• Manufacturer (Section G): OPSENS; 750 blvd du parc technologique; québec, québec G1P4S 3; CA G1P4S3
• Manufacturer Contact: louis grenier ; 750; blvd du parc technologique; québec, québec G1P4S-3 ; CA G1P4S3
• MDR Report Key: 21778027
• Report Number: 3008061490-2025-00001
• Device Sequence Number: 20833176
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)240529(17)260529(10)OSW-0323
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K213854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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 Expiration Date: 05/29/2026
• Device Model Number: X-SMALL
• Device Catalogue Number: F3001
• Device Lot Number: OSW-0323
• 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: 03/07/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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: Death
• Patient Age: 84 YR
• Patient Sex: Male