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

Model Number	F3001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Check of the device history record confirmed that savvywire lot number osw-0093 was released per specifications.No non-conformity nor deviation were associated with this lot.Visual inspection of the returned savvywire identified that the corewire of the tip broke approximately 20 mm from the distal tip.The coil has been uncoiled from the corewire over a length of approximately 8 cm.The provided angio images were reviewed but unfortunately did not capture the event.Opsens reached out to the physician for additional information, he informed us that the case initially went smoothly, valve was successfully implanted using savvywire and delivery system removed.Upon removal, no guiding catheter was used over savvywire, a significant resistance was noticed during the withdrawal attempts.Subsequently, force was applied to exist the femoral site.Savvywire's instruction for use clearly states the following warning: - "the savvywire should only be introduced in, and pulled out from, the ventricle through a catheter already positioned in the ventricle.A diagnostic pigtail catheter is recommended." the following precautions are mentioned in the ifu as well: -" do not grasp the tip.The stiffness of the guidewire may cause it to uncoil unexpectedly if pulled out or manipulated abruptly.- never advance, pull or torque a savvywire against resistance without first determining the reason for the resistance under fluoroscopy.".
Event or Problem Description
The hospital informed opsens that the guidewire's coil peeled away from the corewire during a tavi procedure.A dissection took place at the femoral site when guidewire removed from patient.Patient is in stable condition.

• Brand Name: SAVVYWIRE
• Common Device Name: PRE-SHAPED PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750; blvd du parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer (Section G): OPSENS; 750; blvd du parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: maryem oudhini ; 750; blvd du parc technologique; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 18592421
• Report Number: 3008061490-2024-00001
• Device Sequence Number: 8123536
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)230214(17)250214(10)OSW-0093
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2025
• Device Model Number: F3001
• Device Lot Number: OSW-0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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