MAUDE Adverse Event Report: OpSens Savvywire - Pre-shaped pressure guidewire X-small

Catalog Number	F3001
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/28/2026
Type of Reportable Event	Death
Event or Problem Description
F3001: during the procedure, immediately after valvuloplasty, the savvywire was noted to be kinked.The procedure continued; however, following valve deployment, the patient's aortic pressure did not increase.A perforation of the ventricular wall was subsequently identified.Despite the measures taken, the patient died.
Additional Manufacturer Narrative
The savvywire used in the procedure has not been returned at the time of this report.If the sample has been received and evaluated, a supplemental report will be submitted.Check of the device history records (dhr) of guidewire lot number osw-0421 showed that it was released per specifications.No other complaint was received against this lot.Without inspecting the wire, a visual inspection could not be conducted, therefore no definitive root cause can be established.If there is any further relevant information, a follow-up report will be submitted to the fda.While we cannot confirm that an excessive handling was performed, many warnings and precautions must be considered and are well identified in the ifu.As stated in the instruction for use of the savvywire (lbl-2015-03-v10_en osw ifu_f3001-f3002) under precautions: 1.Confirm the compatibility of the guidewire diameter with the interventional device before actual use.2.Inspect the savvywire for bends, kinks or other damage prior to use.3.Avoid abrasion of the savvywire orange ptfe sleeve.Do not withdraw or manipulate the orange sleeve in a metal cannula or sharp-edged object.4.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.

• Brand Name: Savvywire - Pre-shaped pressure guidewire X-small
• Common Device Name: Savvywire - Pre-shaped pressure guidewire X-small
• Manufacturer (Section D): OpSens; 750 blvd du parc technologique; quebec, G1P4S 3; CA G1P4S3
• Manufacturer (Section G): OpSens; 750 blvd du parc technologique; quebec, G1P4S 3; CA G1P4S3
• Manufacturer Contact: simona jahnke ; quebec, G1P4S-3 ; CA G1P4S3
• MDR Report Key: 50524478
• Report Number: 3008061490-2026-00007
• Device Sequence Number: 13302731
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)241212(17)261212(10)OSW-0421
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K191907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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 Catalogue Number: F3001
• Device Lot Number: OSW-0421
• 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: 08/04/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (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: Death
• Patient Sex: Unknown