MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR RMT THERMOCOOL; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF A

Model Number NI75TCDH

Device Problem High impedance (1291)

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

Event Date 04/24/2014

Event Type  malfunction  

Event Description

Using ablation catheter navistar thermocool d, the impedance was too high.Decision made to switch catheters.Due to patient's body habitus, additional grounding pad added which made impedance lower for continued ablation.Procedure completed without further incident.

• Brand Name: NAVISTAR RMT THERMOCOOL
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF A
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 3333 diamond canyon road; diamond bar CA 91765
• MDR Report Key: 3783163
• MDR Text Key: 4434840
• Report Number: 3783163
• Device Sequence Number: 1
• Product Code: OAD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NI75TCDH
• Device Catalogue Number: 34H37M
• Device Lot Number: 16045457H
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 137