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

Model Number 301

Device Problem Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2018

Event Type  malfunction  

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 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
• Type of Device: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• Manufacturer (Section G): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• Manufacturer Contact: robert lavado ; 309 waverley oaks road; suite 105; waltham, MA 02452 ; 5086533335
• MDR Report Key: 7400392
• MDR Text Key: 104811361
• Report Number: 3007822508-2018-00001
• Device Sequence Number: 1
• Product Code: DXX
• UDI-Device Identifier: 00816280023017
• UDI-Public: (01)00816280023017(11)170922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1