MAUDE Adverse Event Report: CORINDUS INC CORPATH GRX; CORPATH GRX SYSTEM

Device Problem Mechanical Problem (1384)

Patient Problem Vascular Dissection (3160)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

The physician indicated that there was no fine adjustment feature for the guide catheter.The physician was notified that this feature does exist.The training material provided to the physician has the requested feature on the system and the physician was made aware of the feature.No device was returned and the system is functional.

Event Description

Guide catheter induced dissection with acute lad closure.User feedback: there should be an option to select lower amplitude movements of the guide catheter joystick.The joystick movements are too coarse and there should be a finer control option.(analogous to wire control, which can be performed by touchscreen arrows).

• Brand Name: CORPATH GRX
• Type of Device: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS INC; 309 waverly oaks road; waltham MA 02452
• Manufacturer (Section G): CORINDUS INC; 309 waverly oaks road; waltham MA 02452
• Manufacturer Contact: manjusha bharadwaj ; 309 waverly oaks road; waltham, MA 02452
• MDR Report Key: 12795922
• MDR Text Key: 285043484
• Report Number: 3007822508-2021-00004
• Device Sequence Number: 1
• Product Code: DXX
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K173806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• 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
• Patient Outcome(s): Required Intervention