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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/05/2024

Event Type  Injury  

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac tamponade that required pericardiocentesis and prolonged hospitalization.First, due to a poor connection of the reference patch, an intermittent error (error code could not be confirmed) was displayed from 1 hour after the start of the procedure, and the issue could not be resolved even after reconnection.The issue was resolved by replacing the reference patch with another new one.The procedure was completed.It was also reported that patient experienced pericardial effusion.The left ventricular septum and right ventricular septum were ablated with a thermocool® smart touch® sf bi-directional navigation catheter during ablation for vt using carto3.Monitoring was difficult during vt due to poor hemodynamics, and echocardiography showed pericardial effusion at checking after the procedure.After drainage was performed, the blood pressure recovered and the patient left to intensive care unit (icu).The physician's judgment on health hazard was that it was non-serious (moderate/minor).Atrial septal puncture was performed.Ablation was performed at 30-40w before pericardial effusion or tamponade was identified.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting was 15ml.The physician's comment on the relationship between the event and the product: it is highly likely that this event was not caused by the ablation of the smart touch sf catheter, but by the cs catheter entering a space other than the gcv (great cardiac vein).The cs catheter that was used was from another company (lifeline).Transseptal puncture was performed.Ablation had already been performed prior to noticing the pericardial effusion.No error messages observed on biosense webster equipment during the procedure.Patient has improved.

Manufacturer Narrative

On 8-mar-2024, additional information was received indicating the patient did not require extended hospitalization due of the adverse event.The patient¿s outcome was reported as fully recovered.Additional patient details and initial reporter details were received including patient¿s medical history.All new information has been populated into respective fields.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31185048l and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: 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: 18813639
• MDR Text Key: 336617428
• Report Number: 2029046-2024-00688
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31185048L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO3 EXTERNAL REFPATCH 6PACK; CS CATHETER (LIFELINE); OPTRELL, 36 ELECTRODES, D-F; SOUNDSTAR ECO SMS 8F CATHETER; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 65 KG