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

Catalog Number	DI7TCFLRT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The device history record (dhr) for the lot number 17475856m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.On january 7, 2019, the biosense webster, inc.Product analysis lab received the product and it was observed that there was no physical damage upon initial visual inspection.Concomitant medical product: biosense webster, inc.Product - stockert generator, catalog #: unknown, serial #: unknown.Manufacturer's reference : (b)(4).
Event or Problem Description
It was reported that an approximately (b)(6)-year-old female patient underwent an ablation procedure with a celsius¿ thermo-cool¿ electrophysiology catheter and suffered cardiac tamponade requiring epicardial puncture.Initially, it was reported that the catheter presented impedance variation.There was no significant delays to the procedure.There was no patient consequence.Additional information was received on the event on (b)(6) 2018.During the ablation phase, cardiac tamponade was confirmed.Epicardial puncture was performed to remove an unspecified amount of fluid.The patient required an extra day of hospitalization as a result of the adverse event.Patient¿s outcome is improved.There were no factors cited that might have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.The impedance displayed was 150 ohms.The system stopped the ablation when the cut-off value was exceeded.The stockert generator was used at 30 watts with a temperature cut-off value at 43 degrees celsius and a power cut-off at 180 watts.The parameters observed during the procedure included power of 30 watts, temperature of and 37 degrees celsius.The catheter irrigation was set at 30ml/min.The patient received anticoagulant (heparin) during the procedure.The impedance issue was assessed as not reportable.If the impedance exceeds the user-selected cut off, and the generator stopped delivering radio frequency energy as intended, the risk to the patient is remote.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.Therefore, per the information provided on (b)(6) 2018, the awareness date for this reportable adverse event is (b)(6) 2018.
Additional Manufacturer Narrative
Investigation summary: it was reported that an approximately 40-year-old female patient underwent an ablation procedure with a celsius¿ thermo-cool¿ electrophysiology catheter and suffered cardiac tamponade requiring epicardial puncture.Initially, it was reported that the catheter presented impedance variation.There was no significant delays to the procedure.There was no patient consequence.During the ablation phase, cardiac tamponade was confirmed.Epicardial puncture was performed to remove an unspecified amount of fluid.The patient required an extra day of hospitalization as a result of the adverse event.Patient¿s outcome is improved.There were no factors cited that might have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.The device was visually inspected, and it was found in good conditions.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, the irrigation and deflection test were performed, and it was found within specifications, the catheter was irrigating and deflecting correctly.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter passed all specifications.The root cause of the adverse event remains unknown.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer's reference # (b)(4).

• Brand Name: CELSIUS¿ THERMO-COOL¿ 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: 8255000
• Report Number: 2029046-2019-02580
• Device Sequence Number: 1947514
• Product Code: OAD
• UDI-Device Identifier: 10846835000450
• UDI-Public: 10846835000450
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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 Expiration Date: 04/30/2019
• Device Catalogue Number: DI7TCFLRT
• Device Lot Number: 17475856M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 04/04/2019
• 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: Hospitalization; Life Threatening; Required Intervention