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

Model Number	F3001
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Check of the device history record confirmed that savvywire lot number osw-0253 was released per specifications.No non-conformity nor deviation were associated with this lot.The hospital discarded the wire after the procedure.Thus, its inspection was impossible.Basing on the reporter's narrative and the provided angio photo (figure1), the valve system was successfully delivered and the savvywire's tip was showing a kink that has been most likely responsible for perforating the lv wall.The physician commented on the incident, he believes that the patient anatomy caused a lot of pushing when putting the delivery system.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 following precaution are mentioned in the ifu: never advance, pull or torque a savvywire against resistance without first determining the reason for the resistance under fluoroscopy.Excessive force against resistance may result in damage to the wire and/or to the anatomy.Fluoroscopic guidance should be used during manipulations of the savvywire.Care should be taken when the tip of the savvywire is positioned, moved or torqued in the ventricle.
Event or Problem Description
Events as described by opsens's training manager: the savvywire was introduced into the left ventricle, a kink occurred and caused the wire to perforate.The left ventricle wall.Valve was successfully deployed; patient was put on ecmo; then recovered and was taken off same day.

• 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: 19385895
• Report Number: 3008061490-2014-00003
• Device Sequence Number: 15221911
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)230410(17)250410(10)OSW-0253
• Combination Product (Y/N): N
• 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): 05/08/2024

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: 10/04/2025
• Device Model Number: F3001
• Device Lot Number: OSW-0253
• 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: 05/08/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown