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 Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 10/11/2023

Event Type  Injury  

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-02492 for product code (b)(4) (thermocool® smart touch® sf uni-directional navigation catheter).(2) mfr # 2029046-2023-02493 for product code (b)(4) (decanav electrophysiology catheter.

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure using a thermocool® smart touch® sf uni-directional navigation catheter and a decanav electrophysiology catheter and at the end of the procedure, the patient experienced bradycardia and cardiac arrest that required cardiopulmonary resuscitation (cpr), temporary pacing, and prolonged hospitalization.The patient's heart rate got very slow and eventually stopped.The patient was in flutter when they first came in.During the procedure, they were able to get into sinus rhythm but became bradycardic.The physician was trying to mark a his but couldn't and the heart rate became slower and slower.Caller stated they inserted a temporary pacer wire through the neck to help the bradycardia.The heartbeat continued to get so slow that it stopped beating.They did cpr on the patient for about 20-25 mins and shocked the patient to get the rhythm back again.Once they had blood pressure and they were able to capture the heart again, they stopped pacing from the temporary pacing wire and the deca nav catheter.The patient's heart was beating on its own at this point so the temporary pacing wire was removed.The physician did not know what caused the heart to stop but noted that the patient may have been in flutter for so long that the patient may have gone into bradycardia after coming out of flutter.Additional information received indicated the patient required extended hospitalization and then was reported to have improved.The only catheter in the body was a deca nav catheter and a vizigo sheath when the heart stopped but later stated that the soundstar catheter was also in the body.This is being reported under the ablation catheter as the event occurred at the end of the procedure, indicating that ablation did occur.This event will also be captured under the decanav catheter as this was being manipulated inside the body at the time of the event (indicated by physician attempting to "mark a his") and cannot be ruled out as a contributor to the adverse event.The vizigo and soundstar did not have direct contact with cardiac tissue at the time of the event.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation ablation procedure using a thermocool® smart touch® sf uni-directional navigation catheter and a decanav electrophysiology catheter and at the end of the procedure, the patient experienced bradycardia and cardiac arrest that required cardiopulmonary resuscitation (cpr), temporary pacing, and prolonged hospitalization.The patient's heart rate got very slow and eventually stopped.The patient was in flutter when they first came in.During the procedure, they were able to get into sinus rhythm but became bradycardic.The physician was trying to mark a his but couldn't and the heart rate became slower and slower.Caller stated they inserted a temporary pacer wire through the neck to help the bradycardia.The heartbeat continued to get so slow that it stopped beating.They did cpr on the patient for about 20-25 mins and shocked the patient to get the rhythm back again.Once they had blood pressure and they were able to capture the heart again, they stopped pacing from the temporary pacing wire and the deca nav catheter.The patient's heart was beating on its own at this point so the temporary pacing wire was removed.The physician did not know what caused the heart to stop but noted that the patient may have been in flutter for so long that the patient may have gone into bradycardia after coming out of flutter.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 18045884
• MDR Text Key: 327019172
• Report Number: 2029046-2023-02492
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM.; 8.5F SHEATH WITH CURVE VIZ SMC.; SMARTABLATE GENERATOR KIT-US.; SOUNDSTAR ECO GE 8F CATHETER.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male