MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. PENTARAY; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY

Model Number C128208

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/20/2017

Event Type  malfunction  

Event Description

When the catheter was plugged into the system an error message came on screen, another catheter was used (lot number 17670526l) but had the same issue.

• Brand Name: PENTARAY
• Type of Device: CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7032719
• MDR Text Key: 92200142
• Report Number: 7032719
• Device Sequence Number: 1
• Product Code: MTD
• 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: Other
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: C128208
• Device Lot Number: 17685575L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR