MAUDE Adverse Event Report: OPSENS OPTOWIRE III; CORONARY PRESSURE GUIDEWIRE

Model Number F1032

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

Inspection of the optowire iii (ow3) could not be performed since the hospital discarded the device after the procedure.Traceability records were reviewed to identify all optowire lots recently distributed to the hospital.Review of device history record of each lot was performed.All concerned lots were released per specifications.All documented deviations and non-conformity were included as part of the review; all were unrelated with the incident.Opsens reached out the physician for additional comments.The physician confirmed that no device failure contributed to the dissection.Review of the coronary angiograms supported that there was no structural issue with the radio-opaque tip of the guidewire.The tortuosity of the circumflex artery was highlighted by the physician as the primary contributing factor, which was also validated by the angiograms.The physician initially considered that the stiffness of the intermediate section of the optowire iii may be an element of design that was a factor in the dissection.The angiograms did not however provide evidence that the intermediate section of the guidewire could have contributed to the dissection.Opsens reached out to the physician for additional comments.The physician agreed with opsens' assessment.They supported that the patient anatomy and the clinical context were the main causes of the dissection.The risks associated with the event are well documented and are disclosed in the optowire iii instructions for use (ifu): potential complications that may be encountered during coronary angiography and coronary angioplasties include but are not limited to coronary vessel dissection, abrupt closure, occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, myocardial infarction, serious arrhythmias, and death.The physician should be familiar with the literature concerning the complications of angiography.Optowire should be manipulated only under fluoroscopy.Care should be taken when manipulating a guidewire inside a vessel during device placement and removal.Observe optowire movement in the vessels.Before an optowire is moved or torqued, the tip movement should be examined under fluoroscopy.Do not torque an optowire without observing corresponding movement of the tip; otherwise, vessel trauma may occur.Never advance an optowire 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 vessel.If resistance occurs and the cause of resistance cannot be determined, do not move or torque the optowire.Stop the procedure, determine the cause of resistance under fluoroscopy and take appropriate action.No additional action intended as a result of the incident.

Event Description

The physician noticed a distal dissection of the circumflex artery (cx) during use with an optowire iii.The cx presented a severe lesion with calcification and high tortuosity, especially distally.There was no consequence for the patient.The physician was able to cross back with a runthrough and use a balloon catheter to seal the artery.The optowire was not saved by the hospital; coronary angiograms records were made available for the investigation.

• Brand Name: OPTOWIRE III
• Type of Device: CORONARY PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750; boulevard parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: samuel magnan ; 750, blvd parc technologique; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 11031462
• MDR Text Key: 222327360
• Report Number: 3008061490-2020-00006
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2020

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
• Device Operator: Health Professional
• Device Model Number: F1032
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention