MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. NAVVUS CATHETER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number ML00003362

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/30/2017

Event Type  malfunction  

Event Description

Catheter inserted into fractional flow reserve (ffr) console and error message displayed "catheter fault." opened a new catheter and no error message.

• Brand Name: NAVVUS CATHETER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 6379808
• MDR Text Key: 69129554
• Report Number: 6379808
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/15/2017,02/22/2017

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
• Device Operator: No Information
• Device Model Number: ML00003362
• Device Catalogue Number: 14667
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2017
• Event Location: Other
• Date Report to Manufacturer: 02/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1