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 Problems Hepatitis (1897); No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

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; the guidewire displayed no sign of excessive torsion or kink at the fracture point.No evidence of manufacturing issue or material defect was observed.Based on the narrative and results from investigation, difficult insertion into the tortuous and calcified coronary 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.A corrective action is already open.No additional action intended as a result of the incident.(b)(4).

Event Description

4f angiocath was used together with fractured owiii.Equalize was done without problem.Coronary was so tortuous and calcified that the doctor noted difficulty to insert the owiii to lesion.The doctor gave up to insert the wire, but it fractured at around 300mm from tip when withdrawing.The doctor said that he torqued the wire when to insert the wire.The fragment was retrieved by snare.

• Brand Name: OPTOWIRE III
• Type of Device: CORONARY PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750 blvd parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: samuel magnan ; 750 blvd parc technologique; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 10408122
• MDR Text Key: 249162820
• Report Number: 3008061490-2020-00003
• 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: 07/17/2020

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: 02/28/2021
• Device Model Number: F1034
• Device Lot Number: OW-2035D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2020
• 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
• Patient Age: 71 YR