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

Model Number	F3001
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Event as described by opsens clinical specialist: during deployment of valve, upon said final inflation, there may have been loss of capture on wire, patient threw a pvc and valve embolized witevent as described by opsens clinical specialist: during deployment of valve, upon said final inflation, there may have been loss of capture on wire, patient threw a pvc and valve embolized with a pressure spike at 60 mmhg.Upon discussion, physician was unsure of pvc that caused embolization.Further conversation there was suspicion of inflation of valve balloon was incomplete leaving 3-4 more cc's of contrast to complete deployment, allowing a loose valve.Patient had large annulus, bav balloon also shuttled through valve.Doctor repositioned into apex and tested pacing; pressure dropped and had good pacing contact.Patient is doing ok.
Additional Manufacturer Narrative
According to the device history records, lot number osw-0265 was released following specifications.The cause of the lost of capture is unfortunately not determined during this investigation.According to the provided complaint narrative, the patient anatomy (large annulus), the experienced pvc and the balloon incomplete inflation might have contributed to the embolization of the valve.If new findings regarding the investigation were to come up, a secondary report will be filed.The risks associated with the event are well documented and are disclosed in the savvywire instructions for use: "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; quebec, quebec G1P4S 3; CA G1P4S3
• Manufacturer (Section G): OPSENS; 750; blvd du parc technologique; quebec, quebec G1P4S 3; CA G1P4S3
• Manufacturer Contact: maryem oudhini ; 750; blvd du parc technologique; quebec, quebec G1P4S-3 ; CA G1P4S3
• MDR Report Key: 19725389
• Report Number: 3008061490-2014-00004
• Device Sequence Number: 8327883
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)23112711(17)251127(10)OSW-0265
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/13/2024

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: 11/27/2025
• Device Model Number: F3001
• Device Lot Number: OSW-0265
• 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: 06/13/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2023
• 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
• Patient Sex: Unknown