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

Catalog Number 304

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2019

Event Type  malfunction  

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 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
• 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: 8811180
• MDR Text Key: 216361228
• Report Number: 3007822508-2019-00006
• Device Sequence Number: 1
• Product Code: DXX
• UDI-Device Identifier: 00816280023048
• UDI-Public: (01)00816280023048(10)46G2018(17)190731
• 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: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 304
• Device Lot Number: 46G2018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2019
• 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