MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D131503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on (b)(6) 2019.Initial visual analysis observed there was no physical damage the product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.A manufacturing record evaluation was performed for the finished device 30184254l number, and no internal action was found during the review.Manufacturer¿s ref # (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® sf nav uni-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase in the lateral wall, a steam pop occurred.Intracardiac echo (ice) was used and no pericardial effusion was observed.The procedure continued and later, cardiac tamponade was confirmed by ultrasound.Pericardiocentesis was performed to remove 200ml of fluid from the pericardial space.The patient was reported in stable condition after pericardial drainage.No other interventions were necessary.No error messages were observed on any bwi equipment during the case.There¿s no information regarding extended hospitalization or physician causality opinion.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.The reported steam pop issue is not mdr reportable since steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.This event is mdr reportable for the serious injury.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® sf nav uni-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase in the lateral wall, a steam pop occurred.Intracardiac echo (ice) was used and no pericardial effusion was observed.The procedure continued and later, cardiac tamponade was confirmed by ultrasound.Pericardiocentesis was performed to remove 200ml of fluid from the pericardial space.The patient was reported in stable condition after pericardial drainage.No other interventions were necessary.No error messages were observed on any bwi equipment during the case.Device evaluation details: the device was visually inspected and it was found in good conditions.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.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.In addition, irrigation and deflection tests were performed and was found within specifications; the catheter was irrigating and deflecting correctly.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8670089
• Report Number: 2029046-2019-03226
• Device Sequence Number: 10826664
• Product Code: LPB
• UDI-Device Identifier: 10846835009293
• UDI-Public: 10846835009293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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: 02/25/2022
• Device Catalogue Number: D131503
• Device Lot Number: 30184254L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; DEF 7F,20P,DOME,DUO-DECAPOLAR; LASSO NAV 2515,22P SPLITHANDLE; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; CARTO 3 SYSTEM; DEF 7F,20P,DOME,DUO-DECAPOLAR; LASSO NAV 2515,22P SPLITHANDLE; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention