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

Model Number	F1034
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event as described by the medical authorization holder in japan: the operator initialed cag examination for the purpose of ffr.The operator advanced the optowire to the site of severe stenosis but was unable to cross the lesion.During several attempted at wiring, there was no sensation of the wire extension, which was also confirmed by angiographic finding.The operator immediately placed a microcatheter (caravel) over the optowire and retrieved the wire.The guidewire was severed when confirmed outside the body.No broken wire remained in the body.Thereafter, no pci was performed and only an examination was completed.The patient was not injured and was discharged from the hospital at normal schedule.
Additional Manufacturer Narrative
Optowire lot number ow-2336d related to this incident was investigated by the medical device authorization holder.According to the complaint report shared with opsens, the distal side of the broken wire had been discarded by the hospital and only the proximal side of the wire was observed.According to the mah investigation report, the wire was severed near the laser joint welding.The characteristics of the fracture indicated that the guidewire broke from bending fatigue.Based on the narrative and picture of the investigated wire, it is estimated that the repeated attempts to cross the tortuous vessels, combined with the bending of the external proximal side of the guidewire, led to the fracture by bending fatigue of the guidewire's shaft.According to the device history record, optowire iii lot number ow-2336d was released per specifications.No nonconformities or deviations were documented.The risks associated with the event are disclosed in the optowire iii instructions for use (ifu): 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.

• Brand Name: OPTOWIRE III
• Common Device Name: CORONARY PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750; blvd du parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer (Section G): OPSENS; 750; blvd du parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: maryem oudhini ; 750; blvd du parc technologique; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 17652756
• Report Number: 3008061490-2023-00010
• Device Sequence Number: 6331703
• Product Code: DXO
• UDI-Device Identifier: 07540184010325
• UDI-Public: (01)07540184010325(11)220131(17)250131(10)OW-2520E
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2023

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: 01/31/2023
• Device Model Number: F1034
• Device Lot Number: OW-2336D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown