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

Model Number	F1032
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the returned optowire iii confirmed that the guidewire was fractured at 307 mm from its distal end, in the proximal joint of the shaft portion of the device.The proximal fragment displayed a strong kink at the fracture point.Based on the event information provided and inspection of the guidewire, it is estimated that the resistance encountered during the introduction of the guidewire into the guiding catheter caused a significant kink of the guidewire.The subsequence push force led to the fracture of the guidewire at the kink position 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.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.A corrective action request was already put in place by the manufacturer.No additional action intended as a result of the incident.
Event or Problem Description
Event occured in united-states.A guidewire fracture occurred.There was no consequence for the patient.They felt a resistance/kink when they introduced the guidewire in the guiding catheter.They kept advancing the guidewire and it broke at approximately on third from the distal end.The fracture occurred when the optowire was still in the guiding catheter and not in the aorta or coronary.

• Brand Name: OPTOWIRE III
• Common Device Name: CORONARY PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750; boulevard parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• MDR Report Key: 11178471
• Report Number: 3008061490-2021-00001
• Device Sequence Number: 2270718
• Product Code: DXO
• UDI-Device Identifier: 07540184010325
• UDI-Public: (01)07540184010325(11)200602(17)230602(10)OW-2084B
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K191907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2023
• Device Model Number: F1032
• Device Catalogue Number: F1032
• Device Lot Number: OW-2084B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other