MAUDE Adverse Event Report: OPSENS INC. OPTOWIRE DEUX; PRESSURE GUIDEWIRE

Model Number F1014

Device Problem Insufficient Information (3190)

Patient Problem Vascular Dissection (3160)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

Product evaluation: investigation of the device could not be performed because it was not returned for evaluation.A review of the device history record confirmed the device met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the pressurewire and the cause for the reported event remains unknown.The pressurewire instructions for use (ifu) states that vessel dissection is a potential complication which may be encountered during coronary angiography and coronary angioplasties.The pressurewire instructions for use (ifu) states that the user should not torque the pressurewire without observing corresponding movement of the tip; otherwise vessel trauma may occur.Device not returned for investigation.

Event Description

While performing a ffr procedure on a patient with angina pectoris, a coronary dissection occured when the physician tried to deliver the optowire pressure guidewire in lad.No calcification or tortuousness were noted.The dissection was treated with a pci procedure.The procedure was completed.The patient is in a stable condition.

• Brand Name: OPTOWIRE DEUX
• Type of Device: PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS INC.; 750 boul. parc technologique; quebec city, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer (Section G): OPSENS INC.; 750 boul. parc technologique; quebec city, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: stéphane meunier ; 750 boul du parc technologique; quebec city, quebec G1P4S-3 ; CA G1P4S3 ; 4187810333
• MDR Report Key: 6053455
• MDR Text Key: 58301202
• Report Number: 3008061490-2016-00001
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2016

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: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: F1014
• Device Catalogue Number: F1014
• Device Lot Number: OW-0211D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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