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

Model Number	BNI35DFH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30340753l number, and no non-conformances related to the complaint was found during the review.(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis and percutaneous cardiopulmonary support (pcps).Before the procedure started, bubble error occurred with the smartablate¿ irrigation tubing set.The tubing was flushed, and the pump was cleaned and rebooted, but the issue remained.The issue was resolved by replacing the tubing.This issue is not considered to be mdr reportable since there is no risk to the patient as a result of the procedure delay.The procedure continued, atrial tachycardia (at) was mapped and reference was inserted into the left atrial appendage (laa) a ring catheter was used and repeatedly moved inside the laa due to the deviation of the reference.Ablation was then started.After the first ablation near the base of the laa, the patient¿s blood pressure dropped, and cardiac tamponade was confirmed by echocardiography.Reminder of the procedure was aborted.Pericardiocentesis was performed to drain the fluid from the pericardial space; however, patient¿s blood pressure did not restore, and pcps were performed.The physician judged the event as serious and believes the issue occurred due to the ablation.It is unknown if extended hospitalization was required.Patient¿s outcome is unknown.No bwi product malfunctions were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available, it will be reviewed and processed accordingly.
Additional Manufacturer Narrative
On (b)(6) 2020, biosense webser inc.Received additional information indicating the patient was an 81-year-old female.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 10645275
• Report Number: 2029046-2020-01444
• Device Sequence Number: 11619201
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: 10846835003215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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: 01/22/2023
• Device Model Number: BNI35DFH
• Device Catalogue Number: BNI35DFH
• Device Lot Number: 30340753L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 01/05/2021
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE IRR TUBE SET; SMARTABLATE IRR TUBE SET
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 81 YR