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

Model Number F1031

Device Problem Mechanical Problem (1384)

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

Event Date 09/24/2023

Event Type  malfunction  

Event Description

Opsens was informed by the distributor that optowire was advanced into a significantly calcified lesion in the lad, it was noticed that the wire was broken where proximal radiopaque section stops.Wire tip was safely removed, and patient is doing well.Opsens was informed by the distributor that optowire was advanced into a significantly calcified lesion in the lad, it was noticed that the wire was broken where proximal radiopaque section stops.Wire tip was safely removed, and patient is doing well.

Manufacturer Narrative

The optowire iii could not be analysed since it was discarded by the hospital after the procedure.Review of device history records confirmed that the optowire iii lot number ow-2617e had been released as per specifications, dr610 was recorded, but not related to the complaint.Based on the available event description and following discussion with the distributor representative, the wire was fractured at the end of the distal radiopaque section.The cause of the fracture is likely related to the usage of the device beyond the recommendations provided in the instructions for use (ifu): -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.-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.

• Brand Name: OPTOWIRE III
• Type of Device: CORONARY 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: 18060648
• MDR Text Key: 327219021
• Report Number: 3008061490-2023-00011
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07540184010325
• UDI-Public: (01)07540184010325(11)230421(17)260421(10)OW-2617E
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K191907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2023

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: F1031
• Device Lot Number: OW-2617E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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