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

Catalog Number	304
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the system determined that the system was operating as intended at the time of the incident.Per discussion with the personnel involved, the bedside user lifted the guidewire above the axis of rotation during a guidewire rotation move.As such, this caused the guidewire to dislodge from the drive track.This error has the possibility of causing damage to the guidewire.The users have been retrained by corindus clinical personnel as to the proper handling techniques for guidewire management.
Event or Problem Description
Per the facility, during robotic delivery of the guidewire, the wire wrapped around the rear of the rotary drive of the cassette.

• 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: 8811180
• Report Number: 3007822508-2019-00006
• Device Sequence Number: 11550202
• Product Code: DXX
• UDI-Device Identifier: 00816280023048
• UDI-Public: (01)00816280023048(10)46G2018(17)190731
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180517
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: 07/31/2019
• Device Catalogue Number: 304
• Device Lot Number: 46G2018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1