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 02/27/2024

Event Type  Injury  

Event Description

It was reported a patient underwent a pvi cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and patient experienced cardiac tamponade treated with surgical intervention.During the procedure, after about 3.5 hours from the patient entered the room, an ablation catheter was brought to the ridge to ablate the anterior wall of the left superior pulmonary vein (lspv), and the ring electrode was placed in the lspv.The patient was instructed not to take deep breath, as breathing gets deeper during ablation, causing the catheter to move unsteadily and significantly.A few minutes later, the blood pressure dropped progressively from 80 to 60.Due to a blood pressure measurement error in the lab, the connection of the sphygmomanometer was checked.Once the error was resolved, but the blood pressure immediately dropped and it could not be measured with a sphygmomanometer.The patient was conscious, but heart rate was also slowing down, so cardiac tamponade was suspected.Leakage of blood was confirmed by echography.Hastily called a cardiac surgeon and emergency physician and drainage and open chest surgery was performed in the catheterization room.Rf needle was used for transseptal puncture.No steam pops have been confirmed.Irrigation catheter¿s flow rate setting was 15ml at 30w.Additional information was received.Prior to noting the cardiac tamponade, ablation was performed.The adverse event occurred during the ablation phase.Confirmed that switching of the pump flow rate while ablating was not a problem.The patient was admitted in the intensive care unit (icu).During icu admission, dc was performed several times because paf became persistent.Since the patient's condition had stabilized under icu management, the patient was returned to the general ward from the icu.Physician's opinion on cause was procedure and patient condition.The patient¿s breath got deeper during ablation, causing the catheter to move unsteadily and significantly.The physician's comment was that this event was not related to the products, as the effect was due to patient¿s breathing.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31103990la and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).

Manufacturer Narrative

Additional information was received on 22-mar-2024.Patient fully recovered.A blood pressure measurement error in the lab was found.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® 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: 18937734
• MDR Text Key: 338074054
• Report Number: 2029046-2024-00928
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 31103990LA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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: 6FR CS,D,10 POLE,12 PIN,AUTOID; JPN CARTO 3 SYSTEM; SOUNDSTAR ECO SMS 8F CATHETER; UNK PUMP; UNK RF NEEDLE; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 86 KG