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

Catalog Number D134805

Device Problems Device Alarm System (1012); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/30/2023

Event Type  Injury  

Manufacturer Narrative

Device investigation details: information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31088901l number, and no internal action related to the complaint was found during the review.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 an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported atrial septal puncture was performed by rf needle.Blood pressure decrease was noticed while starting pulmonary vein isolation (pvi) of left pulmonary vein (lpv) and ablating per carina in the atrial fibrillation (afib) ablation procedure.Bubble error occurred once at ablation in pvi, and at the last ablation.The ablation was stopped when impedance rose to about 280, was almost 300, but it was thought that the device was working properly.Micro-pop had been felt prior to the blood pressure drop.Cardiac tamponade and pericardial drainage was performed.Patient was in stable condition afterward.The patient was given a hypertensive drug and stabilized afterwards.Patient was conscious and able to communicate.Patient was in the intensive care unit (icu) for a while for observation.The impedance at the ceiling of the left cell where the contact force was high may have been a factor in the ablation.Physician's opinion on the relationship between the event and the product is that there were no errors with the thermocool® smart touch® sf bi-directional navigation catheter not sure if they were related or not; no problems with operation.The physician¿s assessment of the health problem was that it was non-serious (moderate/minor).Ablation had already been performed before the cardiac tamponade was identified.The irrigation catheter¿s flow rate setting was set t2mm <30w:8mm>30w:15mm as per normal setting.Contact force (cf) monitoring methods included dashboard, vector and visitag.Coloring settings for visitag were tag index.Additional filters for visitag included force over time (fot).The patient¿s outcome from the adverse event was reported as improved.

• 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: 17807479
• MDR Text Key: 324135022
• Report Number: 2029046-2023-02160
• 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
• Report Date: 09/25/2023

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 Catalogue Number: D134805
• Device Lot Number: 31088901L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: \
• Patient Sequence Number: 1
• Treatment: 7FR,DEF,20MM DIA., CCW,LASSO; ACUNAV 8F-90; OCTA,STD,48P,2-2-2-2-2,D-CURVE; SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE PUMP KIT (JAPAN); UNKNOWN RF NEEDLE
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female