MAUDE Adverse Event Report: CORINDUS, INC. CORPATH GRX SYSTEM

Model Number	301
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system log files were returned to corindus for evaluation.The evaluation determined that a software communications timing issue occured during the procedure, which caused the system to become unresponsive.A software reboot of the system corrected the issue.The physician was still able to remove the devices from the patient using the emergency device release built into the cassette.As such, no patient injury or complications were reported and the case was able to be completed manually.This issue will continue to be monitored and trended for analysis.
Event or Problem Description
The system became unresponsive when the physician attempted to pull back the support track to manually seat the guide catheter.As a result, the balloon catheter and guidewire were still engaged in the cassette and stuck within the patient.The emergency release button on the cassette was pressed and the cassette was disassembled to remove the trapped devices.No patient injury was reported.

• Brand Name: CORPATH GRX SYSTEM
• Common Device Name: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• MDR Report Key: 7713735
• Report Number: 3007822508-2018-00004
• Device Sequence Number: 1120707
• Product Code: DXX
• UDI-Device Identifier: 00816280023017
• UDI-Public: (01)00816280023017(11)180109
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 301
• Device Catalogue Number: 301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1