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

Model Number D128208

Device Problem Device Inoperable (1663)

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

Event Date 10/03/2017

Event Type  malfunction  

Event Description

Catheter was removed from packaging, inserted and cable was connected to the system, but an error message came up on the display.Catheter was unplugged and reconnected but still didn't work.Another one was used and worked fine.The lot number on new device not available.

• 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: 6990288
• MDR Text Key: 90685309
• Report Number: 6990288
• 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: 10/31/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/03/2020
• Device Model Number: D128208
• Device Lot Number: 17702961L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2017
• Device Age: 3 MO
• 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: 67 YR