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

Catalog Number	BNI35DDH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 venticular contraction (pvc) cardiac ablation with a vizigo sheath and thermocool sf nav catheter and the patient experienced cardiac tamponade that required pericardiocentesis.Two hours after the start of the procedure, after ablating in the right ventricular outflow tract (rvot) for pvc procedure, during re-mapping, the heartbeat was weakened in cine.Cardiac tamponade was suspected and drainage was performed.The procedure was completed as it was.The physician's opinions on the relationship between the event and the product is that there was no forceful manipulation or excessive ablation during mapping or ablating, but based on the timing of noticing the tamponade, there is a possibility that something was caught by the ablation catheter or the sheath.Transseptal puncture was not performed.Ablation was performed prior to identifying the tamponade.No steam pops were confirmed.No abnormalities observed prior to or during use of the product.Additional information was received.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The possibility that the ablation catheter or sheath caught intracardiac tissue cannot be ruled out.Catheter entrapment did not occur.The physician mentioned about the possibility that the catheter or sheath scratched intracardiac tissue and tamponade occurred.The outcome of the adverse event was improved.The ablation never continued beyond the cut-off values.The generator was set to power control mode.
Additional Manufacturer Narrative
During an internal review on 17-aug-2024, noted a correction to the 3500a follow-up #1.Should have included in the h11.Additional manufacturer narrative the following: the bwi product analysis lab received the device for evaluation on 05-aug-2024.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.Therefore, should have also processed the following: -h3.No -h6.Type of investigation: type of investigation not yet determined (b21) -h6.Investigation findings: results pending completion of investigation (c21) -h6.Investigation conclusions: conclusion not yet available (d16) additional information was received on 20-aug-2024.The generator parameters: power control mode, temperature cut-off: 43¿, impedance cut-off: min 50¿, max 250 ¿.Noted temperature, impedance, and power: power: 30w.They could not get the detail information on temperature and impedance, as no ablation that can be identified at which the event occurred.No abnormal temperature or impedance was observed in the ablation record.In addition, provided the patient¿s weight.Therefore, processed a4.Weight of the patient and a4.Weight unit.Also provided update to initially reported concomitant product from unk_smartablate generator to smartablate gen.Kit (japan) therefore, updated d10.Concomitant medical products and therapy dates.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on 31-jul-2024 clarifying that the sheath used was not the bwi vizigo sheath.The sheath used was the slo ((b)(6) medical sheath).Therefore, the bwi vizigo sheath was re-assessed as not mdr reportable.Updated the d10.Concomitant medical products and therapy dates section to the slo ((b)(6) medical sheath).Additional information was received on 15-aug-2024.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The possibility that the ablation catheter or sheath caught intracardiac tissue cannot be ruled out.The ablation never continued beyond the cut-off value.The adverse event was discovered during use of biosense webster products.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a premature venticular contraction (pvc) cardiac ablation with a thermocool sf nav catheter and the patient experienced cardiac tamponade that required pericardiocentesis.The device evaluation was completed on 23-aug-2024.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional information was received on 27-aug-2024.No tissue was found on ablation catheter or the sheath.No cardiac damage occurred.During an internal review on (b)(6) 2024, noted a correction to the 3500a initial under the d4.Primary udi number as it should have been processed as (b)(4).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: 19869183
• Report Number: 2029046-2024-02553
• Device Sequence Number: 7877350
• Product Code: LPB
• UDI-Device Identifier: 10846835003192
• UDI-Public: (01)10846835003192(17)250411(10)30778455L
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/10/2024

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 Expiration Date: 04/11/2025
• Device Catalogue Number: BNI35DDH
• Device Lot Number: 30778455L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 08/17/2024; 08/23/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/21/2024; 08/22/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• 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: OPTRELL, 36 ELECTRODES, D-F.; SMARTABLATE GEN. KIT (JAPAN).; SOUNDSTAR ECO SMS 8F CATHETER.; UNK_CARTO 3.; UNK_CARTO VIZIGO SHEATH.; UNK_SMARTABLATE GENERATOR.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 48 KG