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

Model Number F3001

Device Problem Mechanical Problem (1384)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

Event as described by opsens's sales representative: savvywire (lot #osw-0084) introduced through guide; pacer was tested with no issue with wire; pre-gradients taken with no issue with wire.Balloon (bav) was introduced over the savvywire, and the cardiologist had to apply significant force to cross the stenotic valve.During bav valve crossing, the cardiologist noticed that the guidewire got kink near the sensor housing region.Unfortunately, the kink worsens leading to a guidewire rupture.The physician was able to successfully retrieve the fractured wire element utilizing a snare.The patient was stable, showing no sign of injury upon wire fracture retrieval.Physician then completed the valve intervention successfully and the patient was free of any complication and was discharged from the hospital on normal schedule.

Manufacturer Narrative

Investigation of the returned optowire iii confirmed the information provided by the user, in fact the fracture of wire occurred in the sensor housing on the shaft side of the pressure window both, welding zones of the tip and of the sensor housing looked acceptable.Check of the device history record confirmed that savvywire lot number osw-0084 was released per specifications.No non-conformity nor deviation were associated with this lot.The characteristics of the fracture indicated that the sensor housing broke from excessive bending force.Based on the narrative and the shared angios, excessive force was applied on the wire leading to significant bending at the distal end creating a kink at the sensor housing region.This kink finally reached the maximum bending strength of the material and fracture was noticed by the operator.Opsens reached out to the physician for further comments, and he believes that the tightness of the valve forwarded pressure on the wire and caused its buckling.Following the investigation of the wire, and the gathered information (provided angios and the description of the event), opsens believes that there was a significant amount of force performed on the wire while positioning that most likely generated the kink, then the pressure of the tightness of the valve might have contributed to the fracture of the kinked wire.The risks associated with the unfortunate event are well documented and are disclosed in the savvywire instructions for use (ifu): 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, vasospasm, vessel occlusion, wire entrapment/entanglement, x-ray radiation exposure complications.The ifu also mentions the following precaution such as: 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.

• 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: 17405180
• MDR Text Key: 320131811
• Report Number: 3008061490-2023-00008
• Device Sequence Number: 1
• Product Code: DXO
• 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: 06/28/2023

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-0084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2023
• 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