MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. EZ STEER THERMOCOOL; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number BDI75TCDFRT

Device Problem High impedance (1291)

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

Event Date 12/27/2019

Event Type  malfunction  

Event Description

The biosense webster smartablate generator showed high impedance during an ablation.Another generator obtained.Cable and new ablation catheter replaced.

• Brand Name: EZ STEER THERMOCOOL
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 15715 arrow hwy.; irwindale CA 91706
• MDR Report Key: 10069893
• MDR Text Key: 191430325
• Report Number: 10069893
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/22/2020,01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BDI75TCDFRT
• Device Catalogue Number: BDI75TCDFRT
• Device Lot Number: LOT #-30303138M REF 36Q35M CA
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA