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

Model Number 301

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

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 fo 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 Description

While manipulating the guide catheter from the control console, it was observed that the guide catheter prolapsed at the sheath hub.The case was converted from a robotic to a manual procedure.The case was completed successfully without any patient complications.

• 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: 9281522
• MDR Text Key: 196121488
• Report Number: 3007822508-2019-00010
• Device Sequence Number: 1
• Product Code: DXX
• UDI-Device Identifier: 00816280023017
• UDI-Public: (01)00816280023017(11)190606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 301
• Device Catalogue Number: 301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1