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 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation of the returned optowire iii by the market authorization holder confirmed that the guidewire was fractured at 300mm from its distal end, in the proximal joint of the shaft portion of the device.The characteristics of the fracture indicated that the guidewire broke from fatigue.The guidewire would have failed from repeated pull/push during the attempt the cross the tortuous vessel.No sign of excessive torsion or kink was observed on the guidewire.Based on the narrative and results from investigation, it is estimated that the repeated attempts to cross the tortuous lesion, combined with the use of a diagnostic catheter in place of the recommended guiding catheter, led to the fracture by fatigue of the guidewire's shaft.The cause of the failure is likely related to the usage of the device beyond the recommendations provided in the instructions for use (ifu).Review of device history record confirmed that the optowire lot was released per specifications.No link was established between the incident and the deviations documented on the optowire lot.The investigation did not identify any new risk.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.Confirm the compatibility of the guidewire diameter with the interventional device before actual use.A corrective action request was already put in place by the manufacturer.No additional action intended as a result of the incident.

Event Description

Angiography catheter 5f jl3.5 was used to evaluate ffr / dpr with optowire3.There was strong meandering in the coronary artery (lcx #13) to be accessed, and it was difficult to insert optowire 3.There was a feeling of strangeness in the operation, and when optowire3 was pulled out, it was a fractured near the joint between the shaft and core.Therefore, kusabi (balloon catheter) was inserted into the angiography catheter 5f, and the tip part left in the coronary artery was retrieved.After that, the procedure was completed using the new optowire3.

• 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; boulevard parc technologique; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 11031932
• MDR Text Key: 223807901
• Report Number: 3008061490-2020-00007
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2020

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: 03/31/2023
• Device Model Number: F1034
• Device Lot Number: OW-2051D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• 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