MAUDE Adverse Event Report: SIGHT SCIENCES, INC. VISCO360 VISCOSURGICAL SYSTEM; VISCOELASTIC INJECTOR

Model Number 05172

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

All pertinent information available to sight sciences, inc.Has been submitted.The company is submitting this mdr to ensure full compliance with 21 cfr 803.(b)(4).Submitted to fda on: april 20, 2017.

Event Description

The device was being used to perform viscodilation of the left eye.The microcatheter was advanced 180 degrees.Upon retraction, the surgeon felt resistance.He observed the microcatheter was severed and remained in schlemm's canal.Using retinal forceps, the surgeon successfully removed the catheter from the eye by performing 90 degree goniotomy with the microcatheter and then removing the rest of the microcatheter from the canal.The surgeon used a new device to compete the case.There were no intraoperative or post-operative complications.

• Brand Name: VISCO360 VISCOSURGICAL SYSTEM
• Type of Device: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• Manufacturer Contact: anne-marie ripley ; 3000 sand hill rd., 3-105; menlo park, CA 94025 ; 6616458546
• MDR Report Key: 6508202
• MDR Text Key: 73460066
• Report Number: 3010363671-2017-00017
• Device Sequence Number: 1
• Product Code: MRH
• UDI-Device Identifier: 00858027006020
• UDI-Public: (01)00858027006020(17)171231(10)1005123
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: 05172
• Device Catalogue Number: 05172
• Device Lot Number: 1005123
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• 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 Age: 60 YR