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

Model Number F1031

Device Problem Use of Device Problem (1670)

Patient Problem Vascular Dissection (3160)

Event Date 07/12/2023

Event Type  Injury  

Event Description

Event as described by opsens training and medical education manager: during deployment of 23 mm sapien 3 ultra, capture was lost on a few beats resulting in embolized sapien valve.Valve was pulled to the ascending ao and another valve was implanted utilizing the same savvywire for deployment and rv pacing.Capture was lost during final deployment despite wire not¸ losing position and ground needle secure.Second valve was implanted without issues and patient is doing well.

Manufacturer Narrative

According to the device history records, optowire lot number ow-2585e was released according to specifications, no nonconformities nor deviations were associated with this lot.The wire was investigated after standard decontamination process, visual check of the wire showed that the coating was not striped, also no kinks or deformations were observed.This leads to believe that most likely the torque device was not tightened enough on the guidewire, which explains the poor torque response.The risks associated with the event are well mentioned in the optowire iii instruction of use: "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.Complications resulted from the event are well mentioned in the instruction of use: "potential complications that may be encountered during coronary angiography and coronary angioplasties include but are not limited to: coronary vessel dissection, abrupt closure, occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, myocardial infarction, serious arrhythmias, and death.".

Manufacturer Narrative

According to the device history records, optowire lot number ow-2585e was released according to specifications, no nonconformities nor deviations were associated with this lot.The wire was investigated after standard decontamination process, visual check of the wire showed that the coating was not striped, also no kinks or deformations were observed.This leads to believe that most likely the torque device was not tightened enough on the guidewire, which explains the poor torque response.The risks associated with the event are well mentioned in the optowire iii instruction of use: "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.Complications resulted from the event are well mentioned in the instruction of use: "potential complications that may be encountered during coronary angiography and coronary angioplasties include but are not limited to: coronary vessel dissection, abrupt closure, occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, myocardial infarction, serious arrhythmias, and death.".

Event Description

Event as described by (b)(4) distributor in korea: optowire iii was used in a case, physician was trying to avoid a calcified lesion in lad and optowire iii had caught in a calcified lesion unexpectedly, they tried to retrieve the wire, but physician cannot feel any torque response.They had to use a guiding wire to back up the optowire iii and during this a dissection in the vessel occurred.Physician had to do stenting unexpectedly.

• Brand Name: OPTOWIRE III
• Type of Device: 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: 17572466
• MDR Text Key: 321427115
• Report Number: 3008061490-2023-00009
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K191907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F1031
• Device Lot Number: OW-2585E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2023
• 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