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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Heart Block (4444)

Event Date 11/11/2021

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.In the 1st procedure of paroxysmal atrial fribrilation (paf), pulmonary vein isolation (pvi) was completed, cavotricuspid ishmus (cti) was also completed, pacing was stopped at the timing of differential pacing, and then pacing was resumed because no autologous pulse occurred.At that time, the upper blood pressure decreased to around 60, and the procedure was discontinued.Since cardiac tamponade due to effusion was confirmed by extracorporeal echo, treatment for drainage was performed.Thereafter, the patient's condition was stable, and the patient was followed up in the intensive care unit (icu) after hemostasis.This occurred at the end of the procedure 3 hours and 30 minutes after the beginning of the procedure.After drainage treatment, the condition was stable, and it was followed up in the icu after hemostasis was achieved.The physician commented that it was possible that the patient underwent the procedure in the middle of pvi, but i don't know when.The causality between this event and the product cannot be clearly established because the procedure had been doing it as usual.Additional information was received on the event.The adverse event occurred on (b)(6) 2021.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was the procedure.Drainage was performed.The patient outcome of the adverse event was improved.Prior to noting the cardiac tamponade, ablation was performed.There was no evidence of steam pop.The event occurred during the ablation phase.No error messages were observed on biosense webster equipment during the procedure.

Manufacturer Narrative

Initial reporter phone: (b)(6).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 30610038l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12947118
• MDR Text Key: 281848472
• Report Number: 2029046-2021-02125
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2021

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 Expiration Date: 08/02/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30610038L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention