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

Catalog Number	BNI35DFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31331034l and no internal actions related to the complaint was found during the review.If the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation with a thermocool sf nav catheter and the patient experienced a pericardial effusion that required pericardiocentesis.Pvc procedure with origin in anterior right ventricular outflow tract (rvot).After ablation, the pvc¿s were silent for 7 minutes and then started again.During maneuvering the catheter in the rvot, a pericardial effusion occurred.Due to this, pericardial drainage was needed.500 ml of blood was drawn out the pericardial space.No steam pop or impedance rise was seen or heard during ablation.Ablation settings: 25w, ablation time: 06:25, total ablations: 23.Temperature: max 33 degrees.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
Additional information was received 08-nov-2024.The physician's opinion on the cause of the adverse event is the procedure.The physician thinks it happened during catheter manipulation, not due to ablation.No transseptal puncture was performed.Ablation was performed prior to noting the pericardial effusion.No evidence of steam pop.The perforation was reported to be located in the right ventricular outflow tract (rvot).Patient fully recovered.Therefore, updated the "h6.Health effect - clinical code from cardiac tamponade (e0605) to cardiac perforation (e0604).In addition, provided the patient¿s date of birth, patient's sex and event date.Therefore, updated the following fields: -a2.Date of birth.-a3a.Sex.-b3.Date of event.Also, provided additional concomitant products.Therefore, updated the ¿d10.Concomitant medical products and therapy dates¿ section.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL SF NAV
• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20634701
• Report Number: 2029046-2024-03603
• Device Sequence Number: 20688624
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: (01)10846835003215(17)270515(10)31331034L
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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 Catalogue Number: BNI35DFH
• Device Lot Number: 31331034L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2024
• 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: SMARTABLATE GENERATOR KIT-WW.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Female