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

Model Number D128208

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

After prep of the catheter (flush with hep saline) the device was plugged into the carto station (piu) an error appeared on the screen that there was a sensor error.Cables were switched, device was unplugged and plugged back in, but the error still was presenting on the screen.Another device from the same lot# was used and worked fine.

• Brand Name: PENTARAY NAV
• Type of Device: CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 15715 arrow hwy; irwindale CA 91706
• MDR Report Key: 15498248
• MDR Text Key: 300707007
• Report Number: 15498248
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2022,09/16/2022

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: Health Professional
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30831508L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1