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 Problem Cardiac Tamponade (2226)

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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 (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.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a male patient underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis a few weeks after the procedure.It was reported that a few weeks after a paroxysmal afib case, a pericardial effusion was discovered when the patient showed up at the emergency room complaining of chest pains.The reporter stated that there were no visible signs on the patient during the procedure.The pericardial effusion was confirmed by echo.The medical intervention provided was a pericardiocentesis and it was unknown how much fluid was removed.The patient was reported to be in stable condition.The reporter stated that the physician believed that he may have put an ablation lesion too anterior on the ridge.Additional information was later received indicating the patient¿s outcome from the adverse event was fully recovered.The patient did require extended hospitalization as they were readmitted.A smartablate generator was used during the case with the correct catheter settings selected.Prior to noting the pericardial effusion/cardiac tamponade, ablation had been performed.There was no evidence of steam pop.The reporter states that the event is believed to have occurred in the ablation phase of the procedure.An irrigated catheter was used in the event, with standard flow settings.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.The reporter believes that there were no error messages observed on biosense webster equipment during the procedure.All force visualization features were used.The visitag module was used, the parameters for stability used were 3/3 25%, 3g.The additional filter used with the visitag was impendence.Reporter states that they were not present during this procedure as it was mapped by another bwi representative.Patient presented to hospital 3 weeks post procedure.Details provided are standard for physician.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12978181
• MDR Text Key: 285354838
• Report Number: 2029046-2021-02161
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• 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; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Male