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

Catalog Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Thrombosis/Thrombus (4440)

Event Date 03/29/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a intrauterine fetal supraventricular tachycardia (isvt) ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced deep vein thrombosis, pulmonary embolism, and cardiac arrest that required surgical intervention.It was reported that a venous clot was noticed at the beginning of the case when the sheaths were placed.Before the radiofrequency (rf) was started, the oxygen saturation declined and the patient had a difficult time breathing.The patient was intubated and cpr was started.Clotting was located from the right femoral access up through mid thorax.A team was called in to remove clots from the patient's lungs.The patient required extended hospitalization and was intubated through to (b)(6) 2024).The physician¿s opinion on the cause of this adverse event was procedure itself and the patient's condition.Relevant history includes: low ef (ejection fraction).Patient was anticoagulated before case.The adverse event was noted during use of bwi products.However, no error or product problem was noted.

Manufacturer Narrative

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 31220694l 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.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: 19165410
• MDR Text Key: 340845185
• Report Number: 2029046-2024-01335
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

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: D134804
• Device Lot Number: 31220694L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2024
• 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; SL1 SHEATH; SMARTABLATE GENERATOR; SMARTABLATE PUMP
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male