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

Model Number	X-SMALL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complicated viv case using savvy.Smaller ventricle where ravi reminded tech to keep eye on savvy wire in ventricle since wire kept "coming back".26mm sapien in 26mm sapien.24mm true balloon used to confirm savvy was through center of valve.Bav performed with 24 true.New 26 sapien needed slight balloon inflation to navigate across existing valve.Extended pacing run at 182bpm, 25ma, voo needed during slow deployment.Post valve pressures were in low 70's.Anesthesia gave neo per ravi request.At this point ravi noticed an effusion on tee.Anesthesia stated it was there before case.Pressure did not improve after meds.Anesthesia stated effusion looked worse than initial, pressure now in 60's.Cpr started and surgeon in room placed patient on ecmo and pericardial window performed.After patient stabilized sternotomy performed and surgeon stated bleeding was from lv.Patient taken of ecmo prior to leaving room and currently recovering.Complicated viv case using savvy.Smaller ventricle where ravi reminded tech to keep eye on savvy wire in ventricle since wire kept "coming back".26mm sapien in 26mm sapien.24mm true balloon used to confirm savvy was through center of valve.Bav performed with 24 true.New 26 sapien needed slight balloon inflation to navigate across existing valve.Extended pacing run at 182bpm, 25ma, voo needed during slow deployment.Post valve pressures were in low 70's.Anesthesia gave neo per ravi request.At this point ravi noticed an effusion on tee.Anesthesia stated it was there before case.Pressure did not improve after meds.Anesthesia stated effusion looked worse than initial, pressure now in 60's.Cpr started and surgeon in room placed patient on ecmo and pericardial window performed.After patient stabilized sternotomy performed and surgeon stated bleeding was from lv.Patient taken of ecmo prior to leaving room and currently recovering.
Additional Manufacturer Narrative
The savvywire was discarded, and not returned to the manufacturer.No inspection was possible.Device history records of lot osw-0387 was reviewed and showed that lot was released per specification.No ncr and no deviation were associated with this lot.No other complaint was received on savvywire lot osw-0387.Without inspecting the wire, opsens cannot fully investigate therefore no definitive root cause can be established in this report.If there is any further relevant information, a follow up report will be submitted to the fda.The patient, a 77 year-old woman had a 26mm sapien placed in 2017 and was returning due to paravalvular aortic leakage.Effusion was noted before the procedure.During procedure, effusion worsened and according to the physician, it was 'maybe related to savvy'.A short video of a part of the procedure (well underway at the time of the video) was made available.A small kink on the tip of the wire is visible.To kink a wire in such way, we believe that a high force was applied on the wire and may have contributed to the perforation.However, wire was already kinked at the start of the video indicating that the kink happened before the video.The adverse event resulting 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.

• 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: 23906678
• Report Number: 3008061490-2025-00006
• Device Sequence Number: 9038948
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)241021(17)261021(10)OSW-0387
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/29/2025

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: X-SMALL
• Device Catalogue Number: F3001
• Device Lot Number: OSW-0387
• 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: 12/04/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2024
• 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; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female