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

Model Number F1014

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

This report is a resubmission because it was initially submitted to the test environment (esgtest.Fda.Gov) by error.Original report date was kept.[(b)(4)].

Event Description

Narrative of event, as described by zeon (market authorization holder in (b)(4)): "ffr was tried for rxa#2-3.Dpr was tried then.During doctor's operation, optowire was strayed into rca branch.The doctor tried to push the ow but unfortunately had stuck.Since the coil was stretched, the doctor considered that withdrawing wire will be the trouble because it will reach to ao.The doctor performed emergency pci to cut the stuck ow by rotablator then pressed the fragment to the coronary wall by stent.The doctor considered that this was caused by the procedure, not by the product's problem.".Investigation results by zeon, as described by zeon: "coil was stretched.However, no corrosion observed.Returned material: ow, no gf connector, no foic.Corewire was fractured at 16mm position from distal end.".Patient conditions that could have impacted the procedure: moderate calcification and moderate tortuousness of vessels.Health status of the patient after the procedure: confirmed to be stable.

• Brand Name: OPTOWIRE DEUX
• Type of Device: PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS INC.; 750 boul. parc-technologique; quebec city, G1S 4 S3; CA G1S 4S3
• Manufacturer (Section G): OPSENS INC.; 750 boul. parc-technologique; quebec city, G1S 4 S3; CA G1S 4S3
• Manufacturer Contact: samuel magnan ; 750 boul. parc-technologique; quebec city, quebec G1S 4-S3 ; CA G1S 4S3
• MDR Report Key: 8682639
• MDR Text Key: 148423274
• Report Number: 3008061490-2019-00001
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: F1014
• Device Catalogue Number: F1014
• Device Lot Number: OW-0655D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2018
• 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
• Patient Age: 78 YR