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

Model Number D128211

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  malfunction  

Event Description

Catheter was inserted into patient and could not visualize on mapping system.A new catheter was substituted and was able to visualize.No further problems were noted.It was a catheter malfunction.When the catheter was connected to the cable, there was no signal displayed on the mapping monitor.The catheter was removed and a new catheter was inserted.There were signals with the new catheter.The procedure completed without further problem.No patient injury.

• Brand Name: PENTARAY
• Type of Device: CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 15715 arrow hwy; irwindale, CA 91706
• MDR Report Key: 5735070
• MDR Text Key: 47706946
• Report Number: 5735070
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 17430174L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2016
• Event Location: Other
• Date Report to Manufacturer: 06/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR