MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133602

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Ischemic Heart Disease (2493); Cardiac Perforation (2513)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

The device was reported to be lost by the medical team.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a ventricular tachycardia ablation with a thermocool® smart touch¿ electrophysiology catheter and the patient experienced st elevations, cardiac arrest, and cardiac tamponade that required pericardiocentesis, cpr, and surgical intervention.Initial rhythm was sinus rhythm.Transeptal puncture was performed without complications and this was used as access to left ventricle.During mapping - perhaps 30 mins after ts patient develops st elevations on electrocardiogram (ecg).Extra corporeal membrane oxygenation (ecmo) was performed but there is no effusion to see at this time.Blood pressure (bp) was stable and the elevations lessens after a few minutes.Mapping was continued.After another20-30 mins, the bp dropped and patient lost consciousness.Another echo was performed and a pericardial effusion occurred.Cpr was performed as the bp was too low.The patient still has sinus rhythm but no pulse due to substantial effusion.Pericardial puncture was performed with some difficulty and the effusion was removed from the pericardium.The patient regained consciousness.Procedure was at this point abandoned due to the patient being too unstable to continue.After removing the effusion, the bp and the patient themselves stabilized.The patient was transferred to the icu.During the night the situation worsened and thoracic surgery was performed.A hole in the ventricle was located and patched up.This was likely caused by the pericardial puncture.No ablation was performed and at no point was there a high force on the ablation catheter.Physician's opinion on the cause of this adverse event is the procedure.This event is being coded under the thermocool smarttouch ablation catheter as the event indicates that it was used for mapping (and no other bwi product was involved).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 18412330
• MDR Text Key: 331539269
• Report Number: 2029046-2023-03106
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2023

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 Catalogue Number: D133602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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: NGEN RF GENERATOR; THMCL SMARTTOUCH,TC,F,C3; UNKNOWN SHEATH; UNKNOWN TRANSSEPTAL NEEDLE; UNK_CARTO 3; UNK_OCTARAY NAV
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male