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

Model Number F3001

Device Problem Fracture (1260)

Patient Problem Vascular Dissection (3160)

Event Date 12/08/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 333894078
• Report Number: 3008061490-2024-00001
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)230214(17)250214(10)OSW-0093
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K213854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other