MAUDE Adverse Event Report: ELLEX ISCIENCE INC. ITRACK 250A; CANNULA, OPHTHALMIC

Model Number	IT-250A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As soon as ellex i.Science became aware of the event, the physician was contacted by ellex chief medical officer for further details.The patient had developed a severe inflammatory reaction immediately following canaloplasty but has been improving.The device lot had passed all device performance and sterility tests prior to release.The concerned device was requested back from the user and is under further evaluation.A follow up report shall be provided with updates on the patient status and device investigation.Review of the lot history record for itrack lot# 1810-05 finds that these were built using approved material and released procedures by trained operators.No anomalies were reported.
Event or Problem Description
Doctor reported that the patient on whom he performed the canaloplasty, developed severe inflammatory reaction.
Additional Manufacturer Narrative
The returned catheter from itrack lot# 1810-05 was received, decontaminated and evaluated.The visual inspection of the returned catheter finds a severely kinked and torn area on the distal shaft tubing around 3mm from the tip.Therefore optic fiber and supporting wire were kinked and exposed out of the catheter.This indicates that there was an excessive force applied by forceps while performing the procedure and probably a lot of manipulation when trying to intubate the schlemms canal.The degree of damage to the catheter suggests inappropriate handling/user error.The patient has had persistent inflammatory debris and will likely undergo a vitrectomy to remove the material.Ellex clinical specialist has contacted the user to initiate a visit for additional clinical support to ensure that the user is properly handling the catheter.(b)(4).
Event or Problem Description
This is a follow-up report.The patient has had persistent inflammatory debris and will likely undergo a vitrectomy to remove the material.This report is made by ellex iscience without prejudice and does not imply any admission of liability for the incident or its consequences.

• Brand Name: ITRACK 250A
• Common Device Name: CANNULA, OPHTHALMIC
• Manufacturer (Section D): ELLEX ISCIENCE INC.; 41316 christy st; fremont CA 94538
• MDR Report Key: 8597977
• Report Number: 3005641545-2019-00001
• Device Sequence Number: 19417906
• Product Code: HMX
• UDI-Device Identifier: 00893872001059
• UDI-Public: (01)00893872001059(17)201001(10)181005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection,Notification,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: IT-250A
• Device Catalogue Number: 200478
• Device Lot Number: 1810-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention