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

Model Number F1014

Device Problems Entrapment of Device (1212); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2018

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation concluded the tip corewire was fractured and separated.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.The attempt to pull the wire out of the entrapped position by inducing a torsion and tensile force caused the tip to fail.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.On (b)(6) 2019: this report is a resubmission because it was initially submitted to the test environment (esgtest.Fda.Gov) by error.Original manufacturer report # and original report date were kept.[(b)(4)].

Event Description

Narrative as reported by client: "used for stented left anterior descending artery.Not bifurcated.The physician noticed that the optowire had stuck during operation.He pulled the optowire lightly, but the distal tip has fractured.He tried to withdraw the remained fragment.The fragment was retrieved successfully by snare.".

• Brand Name: OPTOWIRE DEUX
• Type of Device: PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS INC.; 750 boul. parc-technologique; quebec city, G1P 4 S3; CA G1P 4S3
• Manufacturer (Section G): OPSENS INC.; 750 boul. parc-technologique; quebec city, G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: samuel magnan ; 750 boul. parc-technologique; quebec city, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 8686626
• MDR Text Key: 148423612
• Report Number: 3008061490-2018-00004
• 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: 09/28/2018

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: 04/30/2021
• Device Model Number: F1014
• Device Catalogue Number: F1014
• Device Lot Number: OW-0635D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• 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