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

Model Number F1032

Device Problem Mechanical Problem (1384)

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

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation of the returned optowire iii confirmed the information provided by the user, the entire radiopaque section (coil) surrounding the distal tip was completely detached from the core wire (picture 1) 8mm from the distal end of the core wire was also missing, the remaining distal end of the core wire was severely twisted (picture 2 and 3).Check of the device history record confirmed that optowire with lot number ow-2457b was released per specifications.No non-conformity was associated, one deviation was mentioned in the records, but not related to the complaint (lal samples lost during transportation to the test laboratory, rational and risk assessment were performed prior to lot release) hospital was able to report the incident to the fda as follows: "wire tip broke off from the main wire inside the vessel.Was entrapped due to severe calcification".Based on the event information provided from opsens sales rep, the hospital report and inspection of the guidewire, it is estimated that the resistance encountered in the heavily calcified lesion led to the entrapment of the guidewire and the fracture of the tip following significant force that was able to deform the wire (picture2 and 3) and cause its breakage.The missing part from the tip was most likely lodged into the coronary calcified region then jailed behind the stent.No new risk is identified following this investigation.The risks associated with the event are disclosed in the optowire iii instruction for use as follows: - 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.

Event Description

Optowire f1032 lot# ow-2457b was placed in patient lad.Dpr measurement taken.When removing wire (pulling back), the distal tip (entire radiopaque section) detached from the rest of the wire.It was lodged in the coronary that had significant plaque/calcium.Patient stable with no hemodynamic changes.No ekg changes.Physician decided to stent the area thus stabilizing the wire in the coronary.Patient did fine without event post procedure.No patient injury.

• 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; blvrd du parc technologique; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 16380922
• MDR Text Key: 309610088
• Report Number: 3008061490-2023-00002
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07540184010325
• UDI-Public: (01)07540184010325(11)220929(17)250929(10)OW-2457B
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2023

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
• Device Operator: Health Professional
• Device Model Number: F1032
• Device Catalogue Number: F1032
• Device Lot Number: OW-2457B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 29 KG