MAUDE Adverse Event Report: OPSENS OPTOWIRE DEUX; PRESSURE GUIDEWIRE

Model Number F1011

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

Patient Problems Death (1802); Thrombosis (2100)

Event Date 06/21/2018

Event Type  Death  

Manufacturer Narrative

Based on the received narrative, the optowire tip got stuck in a stent placed near a bifurcation lad/d1.The optowire moved backward after stent implementation and was then advance again through the stent.This may have contributed to create a tip entrapment between the stent and the calcified artery wall.The physician tried to pull the optowire out of this entrapment which broke the core wire 14mm from the distal end.The radiopaque coil unwind, as it is supposed, to give a second chance to pull the tip out.Unfortunately the tip was stuck too severely and the radiopaque coil broke.The visual inspection of the device revealed that there is no evidence of weakness in the fracture surface (no design or manufacturing issue).The manufacturing records have been reviewed and the product has been manufactured and released as per specifications.(b)(4).

Event Description

Narrative, as received by opsens: heavily calcified lesion in the lad at the height of the diagonal.After implantation of 2 stents, the optowire came back at little bit, and was advanced through the stents again.During this manoeuvre the wire got stuck halfway the radiopaque and the radiopaque part broke almost completely off.The broken part of the wire formed a loop at the bifurcation lad/d1.The operator implanted a stent-in-stent to secure the piece of wire that broke off in the wall/between the two stents.There was an angiographic successful.After approximately 30 minutes post-procedure the patient developed an in-stent thrombosis post-procedure, for which he needed to be reanimated for 40 minutes and received bypass graft surgery on the lad afterwards.Patient was sent to icu.Current status ((b)(6) 2018) of the patient is still unstable.Last (b)(6) it was decided to extend the artificial sleep in which the patient continues to prolong, after an attempt to awaken him, which showed that the patient had not recovered sufficiently.Update received by opsens: on (b)(6), opsens has been informed that the patient is approachable and awake for about approximate 4 days.The further development of his health state remains to be seen.In addition, due to lung problems the patient had gotten a tracheal tube.On july 20th, opsens has been informed that the patient has passed away on (b)(6).

• Brand Name: OPTOWIRE DEUX
• Type of Device: PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 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: marc dugas ; 750, boul. parc technologique; quebec city, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 8686414
• MDR Text Key: 147573000
• Report Number: 3008061490-2018-00002
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2020
• Device Model Number: F1011
• Device Catalogue Number: F1011
• Device Lot Number: OW-0567A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• 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): Death
• Patient Age: 68 YR