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

Model Number F1031

Device Problems Fracture (1260); Failure to Advance (2524); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2022

Event Type  malfunction  

Event Description

Foreign incident.Patient referred for subacute angio due to nstemi.Radial access.Moderate tortuous brachiocephalic vessels.3 vessels diffuse coronary disease with angiographic stenosis in the distal to mid lad, om2 and midt rca.Diffuse distal disease.Optowire iii pressure measurements of om2, rca and lad.Lad pullback showed focal significant stenosis.Om and rca non significant.Mandate for pci to the lad.Pre-dilatation, stenting and post-dilation.Attempt to perform subsequent pressure measurement post-pci.Opsens wire hard to advance.Tactile feeling is reduced torque and maneuverability.Tip seems locked distal to stent.Maybe, tip-fixation in plaque distal to stent but uncertain.Optowire iii fracture within the guiding catheter.Evacuation of the fractured wire using microsnare (gooseneck snare).No harm or complication was inflicted on the patient.Final stent result satisfactory.

Manufacturer Narrative

Investigation of the returned optowire iii identified that the guidewire fractured in the proximal joint of the shaft portion of the device.The characteristics of the fracture indicated that the guidewire broke from fatigue.The conditions of the distal fragment suggest that the guidewire could have been further damaged during the evacuation by microsnare.The spiral was likely kinked and damaged by the snare.The nitinol inner tube and spiral were also found fractured, indicating a second fracture point.Based on the material properties, fracture of the nitinol inner tube would be indicative that excessive force was applied to the device.A nitinol inner tube fragment estimated to 4mm was missing from the returned device; as per event information, no harm or complication was inflicted on the patient.Review of device history record confirmed that the optowire iii lot was released per specifications.The risks associated with the event are disclosed in the optowire iii instructions for use (ifu):optowire should be manipulated only under fluoroscopy.Care should be taken when manipulating a guidewire inside a vessel during device placement and removal.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.Avoid having optowire to come into contact with stent struts when advancing the optowire into a stented vessel.This may result in entrapment, shredding of the optowire and/or stent dislocation.

Event Description

Foreign incident.Patient referred for subacute angio due to nstemi.Radial access.Moderate tortuous brachiocephalic vessels.3 vessels diffuse coronary disease with angiographic stenosis in the distal to mid lad, om2 and midt rca.Diffuse distal disease.Optowire iii pressure measurements of om2, rca and lad.Lad pullback showed focal significant stenosis.Om and rca non significant.Mandate for pci to the lad.Pre-dilatation, stenting and post-dilation.Attempt to perform subsequent pressure measurement post-pci.Opsens wire hard to advance.Tactile feeling is reduced torque and maneuverability.Tip seems locked distal to stent.Maybe, tip-fixation in plaque distal to stent but uncertain.Optowire iii fracture within the guiding catheter.Evacuation of the fractured wire using microsnare (gooseneck snare).No harm or complication was inflicted on the patient.Final stent result satisfactory.

• 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 (Section G): 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: 13508383
• MDR Text Key: 288173897
• Report Number: 3008061490-2022-00001
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07540184010318
• UDI-Public: (01)07540184010318(11)200604(17)230604(10)OW-2087E
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K191907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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: 06/04/2023
• Device Model Number: F1031
• Device Lot Number: OW-2087E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2020
• 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: 73 YR
• Patient Sex: Male