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

Model Number	D134802
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male patient underwent an persistent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and an ismus®cath electrophysiology catheter with auto id.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that a couple of hours after the procedure was completed, a pericardial effusion was noticed.The patient experienced chest pain and high blood pressure.The pericardial effusion was confirmed with tte.The medical intervention provided was a pericardiocentesis and 500 cc¿s of fluid were removed.The patient was reported to be in stable condition.The physician was unsure of how the issue occurred but that he believed it could have been caused by the 7fr atrial defl cath-carto 3.The patient was being sent home on (b)(6) 2022.Additional information was received.This adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that maybe it was the duadeca catheter.The patient outcome of the adverse event is fully recovered.The patient required extended hospitalization because of the adverse event; he spent the night to be monitored.There was no difficulty in removing the catheter.No ring, electrode or other physical damage was observed at the distal end of the catheter.A transseptal puncture was performed with a brk needle 98 cm.Prior to noting the cardiac tamponade, ablation was performed.There was no evidence of steam pop.The event occurred after the patient left the room.Normal smarttouch sf flow settings were used.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Graph, dashboard, vector, and visitag force visualization features were used.The visitag module was used, parameters for stability used were: range:3mm time :3 sec and for 25% for 3 sec, tag size is 2 mm and no additional filter was used.Impedance color option was used.Clarification provided for a discrepancy on the event description that states, "the physician was unsure of how the issue occurred but that he believed it could have been caused by the ismus®cath electrophysiology catheter with auto id.Response was that the thermocool® smart touch® sf bi-directional navigation catheter was used too.Prolonged hospitalization will not be coded as it was reported it was only one night for observation.Both the thermocool® smart touch® sf bi-directional navigation catheter and ismus®cath electrophysiology catheter with auto id will conservatively be reported in this event as it is unclear which catheter contributed to the event.
Additional Manufacturer Narrative
Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device 30712717l number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15306432
• Report Number: 2029046-2022-01999
• Device Sequence Number: 5339667
• Product Code: LPB
• UDI-Device Identifier: 10846835010152
• UDI-Public: 10846835010152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 02/07/2023
• Device Model Number: D134802
• Device Catalogue Number: D134802
• Device Lot Number: 30712717L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7FR ATRIAL DEFL CATH-CARTO 3; NON BWI-BRK NEEDLE 98 CM; UNKNOWN BRAND GENERATOR; UNKNOWN BRAND PUMP; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male