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

Model Number	305
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.As such, no evaluation could be conducted.Review of the manufacturing records did not indicate any issues with the support track.If the guide catheter prolapses out of the support track, it is possible that the guide catheter could kink and become damaged.It is likely that the lack of support of the guide catheter in this instance was due to a set-up issue by the user.
Event or Problem Description
While manipulating the guide catheter from the control console, it was observed that the guide catheter popped out and buckled.The physician was un-able to re-engage the guide catheter and had to conver the case to a manual procedure.The case was successfully completed manually without any patient complications.

• 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: 9106417
• Report Number: 3007822508-2019-00008
• Device Sequence Number: 11224812
• Product Code: DXX
• UDI-Device Identifier: 00816280023055
• UDI-Public: (01)00816280023055(10)10H2019(17)200630
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K180517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

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 Expiration Date: 06/30/2019
• Device Model Number: 305
• Device Catalogue Number: 305
• Device Lot Number: 10H2019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1