MAUDE Adverse Event Report: OPSENS INC. OPTOWIRE DEUX; PRESSURE GUIDEWIRE, PRODUCT CODE: DXO

Model Number F1014

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

Patient Problem Vascular Dissection (3160)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

The microscopic investigation revealed that the core wire failure was by the applied torsion.The most probable root cause of event is believed to be the reported tortuous and calcified anatomy along with the severity of the lesion which caused the tip to be trapped in place, as reported.The attempt to pull the wire out of the entrapped position by inducing a torsion and tensile force caused the tip to fail.(b)(4).

Event Description

Narrative as reported by distributor: "at (b)(6) 2018 2:00pm, ffr procedure was performed to lad.During second measurement, optowire was trapped and fractured in the lad.Two 0.014 inch gw was delivered and the fractured piece was successfully retrieved.The doctor said that some calcification and tortuousness are observed.The doctor also said coronary #10 was occluded by the dissection which was caused by the retrieving procedure.Pci was performed for stenting and finished with success.Patient is stable.".

• Brand Name: OPTOWIRE DEUX
• Type of Device: PRESSURE GUIDEWIRE, PRODUCT CODE: DXO
• Manufacturer (Section D): OPSENS INC.; 750 boul. parc-technologique; quebec city, G1P 4 S3; CA G1P 4S3
• Manufacturer (Section G): OPSENS; 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: 8683768
• MDR Text Key: 147505579
• Report Number: 3008061490-2018-00001
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: F1014
• Device Catalogue Number: F1014
• Device Lot Number: OW-0490D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• 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: 88 YR
• Patient Weight: 51