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

Model Number F3001

Device Problem Pacing Problem (1439)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

According to the device history records, lot number osw-0237 was released following specifications.Opsens's representative confirmed that pacing and thresholds were successfully tested before the beginning of the procedure.It was also mentioned by the physician that the cause of the lost of capture is unknown, and that he does not believe that savvywire played a role.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.".

Event Description

Event as described by opsens clinical specialist: during deployment of a 26mm valve using savvywire, capture was lost near end of deployment and valve embolization occurred.During staff debriefing post case they mentioned that sometimes bad things can happen even when everything is done correctly, and they did not believe that savvy played a role.Patient is doing well.

• 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: 19097663
• MDR Text Key: 340806027
• Report Number: 3008061490-2014-00002
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)230822(17)250822(10)OSW-0237
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

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-237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2023
• 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