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

Model Number D134804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 09/15/2021

Event Type  Death  

Manufacturer Narrative

Since the event date is (b)(6) 2021, no date of death was provided and the additional information providing the adverse event of death was provided on (b)(6) 2021, added the date of death as (b)(6) 2021.The bwi product analysis lab received the device for evaluation on 07-oct-2021.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6) (date of birth (b)(6)) male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered ventricular fibrillation, cardiac arrest requiring prolonged hospitalization, surgical intervention and eventually death.While ablating the right vein, the patient's blood pressure dropped to the low thirties.They checked for a pericardial effusion via ice (intra-cardiac echocardiogram) and no effusion was noted.They paced the patient to increase the heart rate.They were able to get the patient's heart rate up and they continued to ablate.Then in between lesions, the patient went into ventricular fibrillation and was shocked twice.A code was called and chest compressions and medications were given to the patient.An impella medical device was inserted.All catheters were removed from the patient and the case was aborted.The patient was stable but unconscious and was being transferred to the intensive care unit for observation.They used a decanav catheter, pentaray catheter, thermocool® smart touch® sf bi-directional navigation catheter, a quad in the esophagus, and a vizigo sheath.The physician is not sure what caused the event.The patient had cardiomyopathy and low ejection fraction.The patient had coronary angioplasty and the results were negative for a blockage two months ago.They used 42 max watts on the smartablate generator.Additional information was received on 23-sep-2021.Physician wasn¿t sure of the cause.The patient has severe cardiomyopathy and an ef of 20-30% and has an implantable cardioverter defibrillator (icd), so more patient condition.He did not feel the ablation had anything to do with it.The patient was shocked, given cardiopulmonary resuscitation (cpr), medication and an impella device.Patient outcome of the adverse event was he improved and was transferred to the intensive care unit.Additional information was received on 24-sep-2021.The patient passed away "a few days after the procedure".The cause of death is unknown.The physician believed that the death was not caused by the biosense webster, inc.Product that was sent back.Additional information was received on 1-oct-2021.There were no malfunctions or issues with the product during the case.As mentioned in the complaint, the patient did have an underlying low ejection fraction and blood pressure was noted to be low.There was no evidence of pericardial effusion and the patient¿s rhythm degenerated into ventricular fibrillation in between ablations.Patient condition was what likely contributed to the outcome.The death event was assessed as mdr reportable.All death events where bwi fda approved ¿ ce mark devices are involved, are reportable.

Manufacturer Narrative

It was reported that a 68-year-old (date of birth (b)(6)) male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered ventricular fibrillation, cardiac arrest requiring prolonged hospitalization, surgical intervention and eventually death.The device evaluation was completed on 04-nov-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned product revealed that no damage or anomalies were observed on the smart touch bidirectional sf catheter.Per the event, several tests were performed.Temperature was tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.Magnetic sensor functionality was tested on carto and the catheter failed, error 106 was observed.A failure analysis was performed and the catheter was dissected on the tip area, loss of electrical continuity at the sensor was found, it was determined that the root cause was an internal failure of the sensor.A manufacturing record evaluation was performed for the finished catheter batch number, and no internal actions were identified.As part of biosense webster, inc.¿s quality process all catheters are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated in the carto 3 system manual: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.The instructions 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 catheter that could not be replicated during the analysis.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿adverse event¿.Investigation findings: open circuit (c0205)/ investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the lab finding of ¿internal failure of the sensor¿.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: 12615989
• MDR Text Key: 275913248
• Report Number: 2029046-2021-01733
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30542633M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• 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: SMARTABLATE GENERATOR KIT-US; UNKNOWN BRAND DECANAV CATHETER; UNKNOWN BRAND IMPELLA MEDICAL DEVICE; UNKNOWN BRAND QUAD CATHETER; UNK_CARTO VIZIGO SHEATH; UNK_PENTARAY; SMARTABLATE GENERATOR KIT-US; UNKNOWN BRAND DECANAV CATHETER; UNKNOWN BRAND IMPELLA MEDICAL DEVICE; UNKNOWN BRAND QUAD CATHETER; UNK_CARTO VIZIGO SHEATH; UNK_PENTARAY
• Patient Outcome(s): Hospitalization; Required Intervention; Death
• Patient Age: 68 YR
• Patient Sex: Male