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); Pericardial Effusion (3271)

Event Date 03/30/2022

Event Type  Injury  

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a cardiac tamponade.After pulmonary vein isolation (pvi) was ended, ablation was performed by mapping the atrial tachycardia (at) in the right atrium after left atrial withdrawal.19 ablations were performed.After that, blood pressure decreased during re-mapping.Pericardial effusion was confirmed by echocardiography.The procedure was interrupted, and drainage was performed (later confirmed drainage was not conducted).Atrial septal puncture was performed using rf needle.Ablation was performed before tamponade was confirmed.Steam pop was not confirmed.Irrigation catheter¿s flow setting is low flow 2ml, 30w 8ml.As of the morning of the next day of the procedure, there was no problem and hospitalization were not prolonged.The physician comments that because it was gradual, it was not influenced by ablation or other factors, and the timing/relationship with this product was unknown.Additional information was received indicating the patient outcome of the adverse event was fully recovered.The patient did not require extended hospitalization because of the adverse event.Force visualization features used were dashboard, vector and visitag with an additional filter fot and tag index.

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 was performed for the finished device 30694259l 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 ref.# (b)(4).

Manufacturer Narrative

On 31-may-2022, additional information was received indicating drainage/pericardiocentesis was not performed for this patient.As such, the event has been reassessed to be non-serious and non-mdr reportable since it was confirmed that no pericardiocentesis was performed and that the patient did not require extended hospitalization.Manufacturer's ref.(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 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14197317
• MDR Text Key: 290786694
• Report Number: 2029046-2022-00878
• 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,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30694259L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• 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
• Treatment: CARTO 3 SYSTEM; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, D-F; UNKNOWN RF NEEDLE
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male