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

Catalog Number	BNI35FJCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi failure 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 30089677l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for paroxysmal atrial fibrillation with an thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During post-ablation pacing, the anesthesiologist noted and mentioned to the physician a drop in the patient's blood pressure.Cardiac tamponade was confirmed by transthoracic echo (tee).Pericardiocentesis was performed to remove 300 cc of fluid from the pericardium.The patient was reported to be in stable condition after pericardial drainage.There¿s no information regarding extended hospitalization, patient¿s outcome or physician causality opinion.There were no biosense webster, inc.Product issues reported during the procedure.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.
Additional Manufacturer Narrative
Correction to follow up date received by manufacturer as it was incorrect.The correct date is 11/30/2018.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for paroxysmal atrial fibrillation with an thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.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.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 tests 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.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer's ref.No: (b)(4).

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8021965
• Report Number: 2029046-2018-02231
• Device Sequence Number: 1029671
• Product Code: LPB
• UDI-Device Identifier: 10846835003260
• UDI-Public: 10846835003260
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• 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,Followup
• Report Date (Section B): 10/03/2018

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: 07/04/2021
• Device Catalogue Number: BNI35FJCT
• Device Lot Number: 30089677L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 11/30/2018; 11/30/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/21/2018; 12/21/2018
• 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