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 12/06/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal action related to the complaint was found during the review.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.Initial reporter phone: (b)(6).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 cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring a pericardiocentesis.After mapping the left atrium using pentaray catheter, ablation was started from the ls roof.Blood pressure was confirmed to have gradually decreased about 30 minutes after the start of ablation.Effusion was confirmed by echocardiography, so the procedure was interrupted.Pericardial drainage was performed.After that, since blood pressure was stabilized, the patient is followed up in the intensive care unit.The duration of hospitalization was undecided.There were no abnormalities observed prior to use of the product.Additional information was received indicating the patient¿s outcome from the adverse event was reported as improved.Ablation had already been performed prior to noting the cardiac tamponade.The event occurred during the ablation phase.

Manufacturer Narrative

On 9-jan-2022, additional information about the patient and event were received.It was reported, the physician¿s opinion on the cause of the adverse event and is that the relationship to the bwi product was unknown.A smartablate generator, jll rf needle, irrigation pump and carto 3 systems were used during this procedure.The correct catheter settings were selected on the smartablate generator, the pump flow setting was normally controlled by the generator.The visitag module parameters for stability were range: 3mm, time: 3s, force over time (fot) of 25% and 5g.Force visualization features used included vector, graph, dashboard, main screen view, visitag.The irrigated catheter¿s flow setting was pre-2s and post-3s.There were no filter was used.Color options included other 360/400.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 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: 16067473
• MDR Text Key: 306329375
• Report Number: 2029046-2022-03253
• Device Sequence Number: 1
• Product Code: LPB
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• 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
• Device Lot Number: 30928033L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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; LASSO NAV 2515,22P SPLITHANDLE; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO GE 8F CATHETER; THMCL SMTCH SF BID, TC, D-F; UNKNOWN PUMP
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male