MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133601

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/15/2022

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 female patient underwent an idvt - asc ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that after the procedure was completed, a pericardial effusion was noticed.The bwi representative reported that the patient's blood pressure dropped.The pericardial effusion was confirmed with intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and 200 cc's of fluid was removed.The patient was reported to be in stable condition.Additional information received indicated the adverse event was discovered post use of biosense webster products; post ablation phase.The physician¿s opinion on the cause of this adverse event is that it was patient condition related.The patient had an effusion at baseline that the physician thinks grew due to heparin.The outcome of the adverse event was reported as fully recovered.The patient required extended hospitalization because of the adverse event for monitoring.A smartablate generator was used during the procedure with the correct catheter settings selected on the generator.The pump switching was not from ¿low¿ to ¿high¿ flow during ablation.Transseptal puncture was performed.Ablation had already been performed prior to noting the cardiac tamponade.There was no evidence of steam pop.Theflow setting for the irrigated catheter used was the normal flow settings.Parameters for stability for the visitag module used was range: 2.5 for time: 3sec; force over time (fot) of 3 for 30%; respiratory gated; 3mm tag size.Additional filter used with the visitag was surepoint.Color options used prospectively was tag index.

Manufacturer Narrative

It was reported that a female patient underwent an idvt - asc ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that after the procedure was completed, a pericardial effusion was noticed.The bwi representative reported that the patient's blood pressure dropped.The pericardial effusion was confirmed with intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and 200 cc's of fluid was removed.The patient was reported to be in stable condition.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.However, if the product or product id numbers are 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.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¿ ELECTROPHYSIOLOGY 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: 15980098
• MDR Text Key: 305460546
• Report Number: 2029046-2022-03113
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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: D133601
• Device Catalogue Number: D133601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; SMARTABLATE GENERATOR KIT-US; UNKNOWN PUMP
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female