MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 05/10/2023

Event Type  Injury  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac arrest and cardiac tamponade (ct) requiring a pericardiocentesis, surgical intervention and prolonged hospitalization.It was reported that during an idvt case, a pericardial effusion (pe) was noticed in the patient.They reported that there was initially a steam pop noticed in the patient, and there was a rise in impedance simultaneously.The smartablate generator was set to power control mode, at 50 watts.The smartablate pump was set to the standard smarttouch sf catheter rate of 15ml/min.The patient's blood pressure then dropped about 30 minutes to an hour later in the procedure.The pericardial effusion was confirmed on intracardiac echocardiography (ice).The medical intervention was a pericardiocentesis, and it is unknown how much fluid was removed.They reported that the patient was about to go into ct surgery, when the patient's pulse was lost.Chest compressions were administered to patient.They reported that it is unknown at the time of the call if the patient is stable, but they are being monitored in the operating room (or).Additional information was received.It was reported that the adverse event occurred on (b)(6) 2023.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.Pericardiocentesis was done first, then compressions, then patient was taken to the or for open heart surgery to repair the hole.The patient required extended hospitalization because of the adverse event because of the open heart surgery so had to recover from that and had broken ribs from chest compressions.The patient¿s condition improved.Generator used was smartablate generator, serial #: (b)(6).Dashboard, vector, visitag were used.The, parameters for stability used were 2.5mm for 3 seconds, 3 g for 25%.No additional filter was used with the visitag.Impedance was used.Transseptal puncture was performed with a baylis versacross rf wire.Prior to noting the pe or ct, ablation was performed.There was evidence of steam pop.The event occurred during the ablation phase.An irrigated catheter was used in the event, the flow setting was standard flow setting, high flow of 8, 15 and low flow of 2.Force visualization features used was dashboard, vector, visitag.Visitag module was used, parameters for stability used was 2.5mm for 3 seconds, 3 g for 25%.The steam pop was assessed as not mdr reportable.Steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.The high impedance was assessed as not mdr reportable.Since the user-defined cut-off was not exceeded, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.Since the event (cardiac tamponade) is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

The device evaluation was completed on 14-jun-2023.It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac arrest and cardiac tamponade (ct) requiring a pericardiocentesis, surgical intervention and prolonged hospitalization.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device 31029945l number, and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 17066669
• MDR Text Key: 316573884
• Report Number: 2029046-2023-01230
• 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,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• 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: 31029945L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• 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: SMARTABLATESUPERKIT (G+P+R)-US; UNK BAYLIS VERSACROSS RF WIRE; UNK_CARTO 3; UNK_SMARTABLATE PUMP
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 98 KG