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); Ventricular Fibrillation (2130); Cardiac Tamponade (2226)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 12-mar-2022.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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.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 (b)(6) male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter.The patient suffered a cardiac tamponade requiring a pericardiocentesis and prolonged hospitalization.The patient also experienced a cardiac arrest and ventricular tachycardia.The patient had an implanted cardiac defibrillator (icd) that had recently been used 30-40 times prior to today¿s procedure.The patient was on the table, the icd was disabled and they went into the heart using retro aortic access, and they also created epicardial access.The patient was also on an impella (heart pump) from the beginning of the procedure before doing any mapping.The patient was experiencing ventricular tachycardia that then turned into ventricular fibrillation several times during the procedure.The patient had to be shocked with an external defibrillator approximately 8 times and while waiting for the paddles to charge manual cpr was also administered.The patient also received epinephrine and amnio.After the 7th or 8th external defibrillation, the patient¿s blood pressure dropped.They confirmed the effusion via an intracardiac echocardiogram.A pericardiocentesis was performed and withdrew 600 ml of fluid.The also required blood transfusion.The quantity of the transfusion was unknown at the time of the call.The patient¿s lips were blue several times, indicating hypoxia.No other medical intervention was provided.At the time of the call, the patient was reported stable and was in the intensive care unit.The physician indicated that having the sheath (non bwi) and the soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter in the patient during defibrillation, may have caused the effusion.The case was not part of a study.The physician does not think biosense webster, inc.Product malfunction contributed to the adverse event.After he pulled some catheters at the end of the case, the patient went into vt/vf and required defibrillation.Perhaps a sheath still in the body at the time caused a perforation during the shock administration.The patient was still intubated in the intensive care unit (icu) and having torsade de pointes (polymorphic ventricular tachycardia).The patient required extended hospitalization because of the adverse event in the intensive care unit (icu).The patient has a history of cocaine abuse and myocardial infarction (mi).Transseptal puncture was performed with a brk needle.Ablation was performed prior to noting the cardiac tamponade and there was no evidence of a steam pop.The event occurred post ablation phase after ablation catheter removed.Irrigated catheter was used in the event and the flow setting were set to standard settings.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.Error messages 1007 was observed on biosense webster equipment during the procedure.Force visualization features used were graph, dashboard, vector and visitag with the visitag module parameters for stability set at 3mm, 3sec, 25% 3g with no additional filter used, color option used was impedance.The sheath was not a bwi device.It was also reported that at the beginning of this same case, the carto 3 system crashed during the mapping procedure.The system was rebooted and the study was reopened but then the carto 3 system displayed an error code 1007: chest patch sensor error.The patch unit was replaced and the procedure continued.The software crash issue occurred before the injury.The software crash issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.The c-3 location patch issue was assessed as not mdr reportable.This was highly detectable.Since the adverse event 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 under both the thermocool® smart touch® sf bi-directional navigation catheter and the soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter.

Manufacturer Narrative

Manufacturer's reference number: (b)(4) during an internal review on 18-mar-2022 noted a correction to the 3500a initial as missing the patient consequence code of ventricular fibrillation.Therefore, added to "h6.Health effect - clinical code" field.

Manufacturer Narrative

Initially the concomitant product of decanav catheter was reported in the 3500a initial report.Additional information received on 22-mar-2022, updated the product to 7fr decan,11p,f,2.4mmle,282mm.Therefore, updated d10.Concomitant medical products and therapy dates field.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a 45-year-old male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter.The patient suffered a cardiac tamponade requiring a pericardiocentesis and prolonged hospitalization.The patient also experienced a cardiac arrest and ventricular tachycardia.The device evaluation was completed on 19-apr-2022.The product was returned to biosense webster for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, temperature, and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.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 ifu (instruction for use) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.In addition, the lot number was retrieved during the device evaluation.Therefore, processed d4.Lot, d4.Expiration date and h4.Device manufacture date.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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13816338
• MDR Text Key: 289534758
• Report Number: 2029046-2022-00568
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30657088L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,.; CARTO 3 SYSTEM.; DECANAV CATHETER.; NON BWI - SHEATH.; NON BWI- BRK NEEDLE.; SOUNDSTAR ECO GE 8F CATHETER.; UNKNOWN BRAND PUMP.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male