MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ DS ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	D7TCF8L162RT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: smartablate generator (model# m-4900-407, serial# unknown).(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial flutter with a celsius¿ ds electrophysiology catheter and suffered a cardiac tamponade requiring surgical intervention.During ablation, a steam pop was heard.Ablation was stopped.Patient was assessed.Blood pressure and heart rate remained stable and the patient did not express pain.Procedure resumed.Analgesics (unspecified) were administered per ablation protocol.At that point, patient became hypotensive and unresponsive.Transthoracic echocardiography (tte) revealed a cardiac tamponade.Pericardiocentesis was ineffective, as blood had coagulated.Patient was transferred to the cardiothoracic operating room, where an atrial perforation was detected.There is no information regarding extended hospitalization or patient outcome.There were no patient factors cited that may have contributed to the adverse event.Physician did not provide a causality opinion.There were no issues, errors, or malfunctions reported on any bwi products or equipment during the procedure.No transseptal puncture was performed.There is no sheath information.Generator was set on temperature control mode.There is no information regarding generator parameters, generator settings, power titration, overall ablation time at the site of injury, last ablation cycle time at the site of injury, irrigated catheter flow setting, or anticoagulation during the procedure.

• Brand Name: CELSIUS¿ DS ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7612409
• Report Number: 2029046-2018-01688
• Device Sequence Number: 11175711
• Product Code: OAD
• UDI-Device Identifier: 10846835000399
• UDI-Public: 10846835000399
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P010068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: D7TCF8L162RT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention