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

Catalog Number D134804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 09/12/2023

Event Type  Death  

Manufacturer Narrative

Additional 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.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 flutter (afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac arrest and ultimately passed away.There was a patient death after the procedure.There were no issues with the patient or with any of the biosense webster, inc.Products during the procedure.After the procedure, all the catheters were pulled from the body and pressure was applied to the patient's groin.The patient was fine before they left, but a short time later, the patient's blood pressure dropped.Caller was told that the patient was checked for a pericardial effusion using echocardiogram but none was found.They tried to intubate the patient and the medical intervention included " cardiopulmonary resuscitation (cpr) for 30 minutes before they called it." this is the only information that the caller was given.They were not aware of any injury to the patient.Caller was informed today of the patient's death and does not know what the official cause of death was for the patient.They did not have the serial number for the smartablate generator used during the procedure at the time of the call.The carto 3 system used was serial# (b)(6).The only catheters used during the procedure were a webster cs catheter and an stsf catheter.Additional information was received.The adverse event was discovered post use of biosense webster products.Physician¿s opinion on the cause of this adverse event was the patient¿s condition.Cpr was the intervention done.Outcome of the adverse event was death.Patient did not require extended hospitalization because of the adverse event.In physician¿s opinion, the cause of death was unsure.

• 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: 17950154
• MDR Text Key: 325855548
• Report Number: 2029046-2023-02342
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2023

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: D134804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/17/2023
• 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: CARTO 3 SYSTEM; UNK_SMARTABLATE GENERATOR; WEBSTER CS
• Patient Outcome(s): Life Threatening; Death; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male