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

Model Number	301
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was conducted where by the joystick was disassembled upon return.It ws discovered that the joystick had been over-torqued by the user.This over-torquing caused to potentiometer of the joystick to stay out of the dead band and as such, left the joystick in a position that an active voltage was constantly applied keeping the system in a driving mode while the operator was touching the joystick, even if the joystick position was in the dead band zone.Overall, this issue was caused by mis-use of the system.
Event or Problem Description
While using the corpath grx system for a pci procedure, the physician attempted to advance the guidewire, he noted that the guidewire was responding more than usual.The joystick was moved to the first variable speed level, but the guidewire was moving faster than anticipated.The same issue occured when attempting to rotate the guidewire.Eventually an alarm and error sounded on the control console instructing to "release joystick." the case was converted to a manual procedure and was successfully completed.

• 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: 7400392
• Report Number: 3007822508-2018-00001
• Device Sequence Number: 1292193
• Product Code: DXX
• UDI-Device Identifier: 00816280023017
• UDI-Public: (01)00816280023017(11)170922
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Repair
• Type of Report: Initial
• Report Date (Section B): 04/03/2018

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: Physician
• Device Model Number: 301
• Device Catalogue Number: 301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1