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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/14/2022

Event Type  Injury  

Event Description

It was reported that an 80-year-old male underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade.Cardiac tamponade occurred while conducting mapping with an ablation catheter in the coronary sinus.The patient¿s progress, there was no major problems.Atrial septal puncture was not performed.Ablation was performed before tamponade was identified.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting was high 8-15ml and low 2ml, pre rf time:1, post rf time:2.The physician's opinions on the relationship between the event and the product was that there is no relationship with the product.There were no abnormalities observed prior to and during use of the product.There was no relevant medical history or tests.Additional information was received indicating the physician commented that there was no relationship with bwi products.Real time graph; dashboard; vector; and visitag force visualization features were used.Tag index color option was used.There is no further information about the hospitalization and if any additional intervention was performed.

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.Initial reporter phone: (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).

Manufacturer Narrative

On 27-dec-2022, additional information was received indicating that no intervention was provided.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 12-jan-2023, additional information was received indicating the patient did not require extended hospitalization.A smartablate generator utilized during this procedure with the correct catheter settings selected on the generator and the pump flow setting was normally controlled by the generator.No error messages were observed on the biosense webster equipment during the procedure.Visitag module parameters for stability were range: 2, time: 3, force over time (fot):5% and 5g, tag size:3.No additional filter used with the visitag.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that an 80-year-old male underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade.Cardiac tamponade occurred while conducting mapping with an ablation catheter in the coronary sinus.The patient¿s progress, there was no major problems.Atrial septal puncture was not performed.Ablation was performed before tamponade was identified.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting was high 8-15ml and low 2ml, pre rf time:1, post rf time:2.The physician's opinions on the relationship between the event and the product was that there is no relationship with the product.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.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 with lot # 30892346l and no internal actions 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: 15968004
• MDR Text Key: 305341460
• Report Number: 2029046-2022-03093
• 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,Followup,Followup
• Report Date: 06/23/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30892346L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/27/2022; 01/12/2023; 05/26/2023
• Supplement Dates FDA Received: 01/05/2023; 02/03/2023; 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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: CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; OCTA,STD,48P,2-2-2-2-2,D-CURVE; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE IRR TUBE SET; UNKNOWN PUMP
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 76 KG