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

Model Number F1011

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation concluded the tip corewire had been fractured, but both ends remained attached to the coil.The combined length of tip corewire sections indicated there was no part left in patient.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.No material defect was noticed on corewire portion.The investigation showed that the corewire was twisted over multiple turns.According to ifu: 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.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

Narrative as reported by client: "during a ffr procedure in tortuous circumflex, the ow went into a collateral.The physician pulled the wire in order to reposition it which induced its stretching.The physician managed to entirely remove the wire from the patient with an emergency procedure using a balloon.There was no clinical impact on the patient.".

• 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 G1S 4 S3; CA G1S 4S3
• Manufacturer Contact: stéphane meunier ; 750 boul. parc-technologique; quebec city, quebec G1S 4-S3 ; CA G1S 4S3 ; 8781 0333
• MDR Report Key: 6267847
• MDR Text Key: 65781200
• Report Number: 3008061490-2017-00001
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K152991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2017

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: Physician
• Device Expiration Date: 09/09/2019
• Device Model Number: F1011
• Device Catalogue Number: F1011
• Device Lot Number: OW-0242A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2016
• Initial Date FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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
• Patient Age: 78 YR