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 Arrest (1762); Cardiac Tamponade (2226)

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

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 31047097l 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.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) - right ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient suffered cardiac tamponade (ct) and cardiac arrest requiring prolonged hospitalization.It was reported that after mapping a premature ventricular contraction (pvc) with a decanav, the stsf was inserted for ablation.Three radiofrequency (rf) applications were performed.They stated that no ablation data readings were unusual.During the post-ablation waiting period, the patient started moving on the table (the ablation catheter was in the body at this time).About 2-4 minutes later, asystole was noted on the monitor, which then changed to pulseless electrical activity (pea).Cpr was initiated.A 10f soundstar was initially inserted but would not pass through the abdominal area.An 8f soundstar was then inserted by a consulting physician and a "significantly large effusion" was noted on ice imaging, approximately 2 cm.A pericardiocentesis was performed.The adverse event was discovered during use of biosense webster inc.(bwi) products.Transseptal puncture was not performed.Prior to noting the pericardial effusion or cardiac tamponade, ablation was performed.There was no evidence of steam pop.The event occurred post ablation.Irrigated catheter was used in the event, the flow setting was 8/15ml per ifu.No error messages observed on biosense webster equipment during the procedure.The patient was hemodynamically stable at the time of the call.The effusion was discovered/noticed via intracardiac echocardiography (ice) imaging.It was confirmed with a soundstar 8f.Pericardiocentesis was performed, unknown how much fluid was removed, still in progress at the time of the call.The procedure was abandoned.Evidence of any effusion present before the procedure was not confirmed as no ultrasound imaging at the start of the procedure.Other bwi products used were soundstar 8f (10439236/g9307090), decanav (r7f282ct/30878953m).The ablation catheter will not be returned for analysis as it was discarded.No replacement requested.Additional information was received, and it was reported that the patient was stable, condition improved and has been transferred from icu to tcu.Patient was still hospitalized at the time of reporting, but no knowledge of reason for extended stay.Generator information was stockert smartablate, g4c-0240.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.Graph , dashboard , vector were used.

• 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: 17321722
• MDR Text Key: 319025959
• Report Number: 2029046-2023-01511
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 31047097L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0055-2018
• Patient Sequence Number: 1
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,; SMARTABLATE GENERATOR KIT-US; SOUNDSTAR ECO GE 10F CATHETER; SOUNDSTAR ECO GE 8F CATHETER; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male