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 Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation of the returned optowire iii showed that the guidewire was fractured at 30cm from its distal end, in the proximal joint of the shaft portion of the device.The combined length of the proximal and distal fragments confirmed that no part was left behind in the patient.The characteristics of the fracture indicated that the guidewire broke from fatigue.The guidewire would have failed from repeated pull/push; no sign of excessive torsion or kink was observed on the guidewire.No evidence of manufacturing issue or material defect was observed.Based on the narrative and results from investigation, it is estimated that the repeated attempts to cross the complex calcified distal lesion lead 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.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.Even though the proximal joint meets strength requirements established for guidewires in applicable safety and performance standards, a corrective action request was opened as a result of the reported complaint to further investigate the cause of the failure and attempt to improve resistance of the guidewire in such cases.

Event Description

Ow3 was used for lad#6, complexed calcified lesion.Equalized without problem.The doctor tried insert the ow3, but it cannot cross the distal lesion.He tried to cross for several times, but it was not accomplished.The doctor decided to try ffr at that position, however, any value was not shown on the display unit.The doctor thought that fiber breakage might have been occurred, he tried to withdraw the ow3.But angiograph showed that distal fragment was remained in the vessel.Since the proximal part of the fractured wire was in the guiding catheter, it was retrieved by pressing the fragment to the guiding catheter by balloon catheter.The fragment length was about 25cm.Alternative ffr was not performed then.The doctor said that ow3 was not stuck, no extreme force was applied then.Ow3 was used for lad#6, complexed calcified lesion.Equalized without problem.The doctor tried insert the ow3, but it cannot cross the distal lesion.He tried to cross for several times, but it was not accomplished.The doctor decided to try ffr at that position, however, any value was not shown on the display unit.The doctor thought that fiber breakage might have been occurred, he tried to withdraw the ow3.But angiograph showed that distal fragment was remained in the vessel.Since the proximal part of the fractured wire was in the guiding catheter, it was retrieved by pressing the fragment to the guiding catheter by balloon catheter.The fragment length was about 25cm.Alternative ffr was not performed then.The doctor said that ow3 was not stuck, no extreme force was applied then.

• Brand Name: OPTOWIRE III
• Type of Device: CORONARY PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750 blvr du parc technologique; québec, québec G1P4S 3; CA G1P4S3
• Manufacturer Contact: samuel magnan ; 750 blvr du parc technologique; québec, québec G1P4S-3 ; CA G1P4S3
• MDR Report Key: 10323173
• MDR Text Key: 219529955
• Report Number: 3008061490-2020-00002
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2021
• Device Model Number: F1034
• Device Lot Number: OW-2035D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2020
• 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): Required Intervention