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 Perforation (2513)

Event Date 10/09/2023

Event Type  Injury  

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.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).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure using thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac tamponade / perforation that required surgical intervention.Ablation was performed on the cavo-tricuspid isthmus and posterior wall of the right atrium.The physician then performed a transseptal to obtain access to the left atrium.The patient's blood pressure decreased and the physician utilized the soundstar ice images to evaluate the pericardial space and confirmed a pericardial effusion.The physician performed a pericardiocentesis procedure and removed fluid from the patient's pericardial space.After the pericardiocentesis procedure, the patient was stable but the fluid was still being removed.The amount of fluid removed is unknown by the caller.The patient was then transferred to the operating room for further intervention.Physician believed the left atrial appendage was perforated during the transseptal access.Ablation was performed prior to noting the pericardial effusion, although the thermocool® smart touch® sf bi-directional navigation catheter was noted to not be in the body when the event occurred.No evidence of steam pop.The event occurred during the transseptal phase.Caller reported that per her knowledge the patient recovered.There is no information about the hospitalization.

• 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: 18066406
• MDR Text Key: 327298758
• Report Number: 2029046-2023-02517
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Physician
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/03/2023
• 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: AGILIS SHEATH; BAYLIS NRG TRANSSEPTAL NEEDLE; BWI SOUNDSTA; UNK PUMP; UNK_CARTO 3; UNK_NGEN RF GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male