MAUDE Adverse Event Report: OPSENS OPTOWIRE III; CORONARY PRESSURE GUIDEWIRE, PRODUCT CODE: DXO

Model Number F1032

Device Problem Mechanical Problem (1384)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

The event was reported as following from the physician to opsens sales representative: the wire was inserted into a calcified rca and as the physician was advancing the wire down the vessel, he noticed that the tip would no longer torque and appeared to be stuck in a calcified lesion.Without thinking about it, the physician pulled somewhat forcefully on the wire and the wire came back, but he noticed that the distal tip was not attached.The distal cap of the wire remained in the calcified lesion and the thin wire coil had unwrapped and was still in the patient's right coronary artery and beyond.After a few hours, most of the unwrapped coil was removed from the patient, but a small segment of wire (distal cap and coil) was left in the rca with a small section protruding into the aorta.The physician did not feel that the wire was at fault and stated that he should not have pulled it forcefully when the tip was initially stuck in the calcified lesion.The wire was discarded and not available for analysis.Opsens was not informed of any patient complications after the incident.

Manufacturer Narrative

Inspection of the optowire iii could not be performed as the hospital discarded it by the end of the procedure.A full check of all optowire lots distributed recently to the hospital was performed, review of device history record of each lot number was done, all lots were released per specifications, no deviations nor non-conformities were recorded.The physician confirmed that the optowire was not at fault and that he should not have pulled the guidewire forcefully when the tip was stuck in the very calcified lesion.Opsens concludes that the patient anatomy and the forceful handling of the physician has contributed to the breakage of the optowire tip in the optowire iii instructions for use (ifu) under warnings: 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 further actions are intended as a result of the incident.

• Brand Name: OPTOWIRE III
• Type of Device: CORONARY PRESSURE GUIDEWIRE, PRODUCT CODE: DXO
• Manufacturer (Section D): OPSENS; 750; boulevard parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: maryem oudhini ; 750; boulevard du parc technologiqu; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 16358531
• MDR Text Key: 309608854
• Report Number: 3008061490-2022-00003
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07540184010325
• UDI-Public: (01)07540184010325(11)AAMMJJ(17)AAMMJJ(10)OW-XXXXY
• 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: 10/12/2022

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: F1032
• Device Catalogue Number: F1032
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 02/10/2023
• 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): Other