MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. NAVVUS CATHETER; CATHETER, PRESSURE MONITORING, CARDIAC

Catalog Number 014667

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/23/2015

Event Type  malfunction  

Event Description

Upon connecting catheter to console, baseline readings were abnormal and showed fluctuation.Waveform on the scale did not remain steady at baseline.Digital numbers fluctuated above normal.

• Brand Name: NAVVUS CATHETER
• Type of Device: CATHETER, PRESSURE MONITORING, CARDIAC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 5194361
• MDR Text Key: 30028157
• Report Number: 5194361
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 014667
• Device Lot Number: ML00002845
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR