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

Catalog Number	BNI35BFH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/01/2019
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.A manufacturing record evaluation was performed for the finished device 30116345l number, and no internal actions was found during the review.Manufacturer's reference (b)(4).
Event or Problem Description
It was reported that a male patient underwent an ablation procedure with an thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During mapping phase, cardiac tamponade was confirmed.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.Extended hospitalization was required as a result of the adverse event.Patient¿ outcome is improved.The physician¿s opinion regarding the cause of the adverse event is unknown.No error messages were observed on any biosense webster, inc.Equipment during the procedure.Transseptal puncture was not performed.No ablation occurred prior to the adverse event.The catheter irrigation was set at 2 ml/min in low flow.
Additional Manufacturer Narrative
During an internal review on (b)(6) 2019, it was noted that manufacturer address street line 1¿ on the 3500a initial report needed correction.It was initially submitted as ¿31 technology drive¿.The correct address is ¿33 technology drive¿.Therefore, ¿manufacturer address street line 1¿ has been re-populated.Investigation summary it was reported that a male patient underwent an ablation procedure with a thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During mapping phase, cardiac tamponade was confirmed.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.Extended hospitalization was required as a result of the adverse event.Patient¿ outcome is improved.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 test were performed, and it 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 reference # (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: 8483866
• Report Number: 2029046-2019-02947
• Device Sequence Number: 2015025
• Product Code: LPB
• UDI-Device Identifier: 10846835003178
• UDI-Public: 10846835003178
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030031/S025
• 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): 03/07/2019

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: 09/12/2021
• Device Catalogue Number: BNI35BFH
• Device Lot Number: 30116345L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/14/2019
• 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
• Patient Age: 52 YR
• Patient Weight: 113