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

Model Number F1034

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

The guidewire could not be analysed since it was discarded by the hospital after the procedure.Review of device history records confirmed that the optowire iii had been released as per specification.Based on the available event information, the cause of the failure was likely related to the usage of the device beyond the recommendations provided in the instructions for use (ifu).Usage of the optowire of is recommended with guiding catheter.As per ifu:advance the optowire through guiding catheter using the appropriate guidewire introducer.The risks associated with the event are disclosed in the optowire iii 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.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.Do not use the optowire if any portion of the device or packaging appears damaged, if any portion of the sterile pouch has been opened or if product is expired.Onfirm the compatibility of the guidewire diameter with the interventional device before actual use.

Event Description

Foreign incident.During the procedure, the physician felt that there was a bit of friction with the guidewire and decided to withdraw the wire from the diagnostic catheter (terumo optiflash bl3.5sh).After removing the wire, a substantial portion had remained inside the catheter.The physician successfully removed the fractured segment by snare.There was no injury.

• 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 (Section G): OPSENS; 750; boulevard parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: samuel magnan ; 750; boulevard parc technologique; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 14790243
• MDR Text Key: 303160856
• Report Number: 3008061490-2022-00002
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2022

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 Expiration Date: 05/31/2024
• Device Model Number: F1034
• Device Lot Number: OW-2230D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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