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

Catalog Number D134702

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 10/24/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure which included the use of a thermocool® smart touch® sf uni-directional navigation catheter.The patient experienced cardiac perforation treated with a pericardiocentesis, application of a drain for residual blood loss from the perforation and admitted into the intensive care unit (icu).Transseptal was performed with baylis nrg needle.While they were ablating the posterior wall and had moved along the roof outside of the left superior vein, the physician noticed an effusion developing on ice using the soundstar catheter.The reporter was unsure of how much fluid was drained but stated that it was upwards of 800 cc's and was re-delivered back to the patient.The patient improved as the physician recognized the effusion in a timely manner and managed it immediately.There was no evidence of steam pop or impedance rise.The physician believed there was "a specific lesion ablation with a force value of 50 max for 1 to 2 seconds" during the procedure that may have caused the effusion.The physician's opinion as the cause is the patient's condition of being an elderly patient with thin heart tissue.

Manufacturer Narrative

The device has been reported as discarded, therefore 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.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 UNI-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: 18145614
• MDR Text Key: 328224888
• Report Number: 2029046-2023-02663
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2023
• 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: BAYLIS NRG NEEDLE; SMARTABLATE GENERATOR KIT-US; UNK_DECANAV CATHETER; UNK_PENTARAY CATHETER; UNK_PUMP; UNK_SOUNDSTAR CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female