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

Model Number D134805

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

Patient Problem Tachycardia (2095)

Event Date 03/25/2022

Event Type  Death  

Manufacturer Narrative

The device has been reported as discarded, therefore 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.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 an (b)(6) male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered tachycardia and ultimately death.It was reported that the patient had a complication during the procedure and died within the next two days.The patient had a history of coronary bypass and an aortic valve replacement.They had difficulty crossing the prosthetic valve, but they were able to and mapped the premature ventricular contraction (pvc) on the right/left commissure.They came on ablation once or twice.Then "fell back across the valve." they went back across the valve a second time and ablated "two or three more times for a total of five ablations." it was at this time they noticed ekg changes: st-elevation in aortic valve replacement (avr) and st depression in inferior and precordial leads.The patient had been bradycardic the whole procedure and at this time became tachycardic.The physician then used an intracardiac echocardiogram to observe an anterior apical wall motion abnormality.At this point, the case was aborted, nitroglycerine was administered, and a stat echo was ordered, and an interventional cardiologist was consulted.The st changes normalized after about 20 minutes and the patient was sent to the cath lab where the stat echo was performed, and they catheterized the patient; they shot contrast dye into the arteries to see if any obstruction was causing the st changes.The cath was normal and the echo was normal, and the patient was kept overnight for observation and discharged saturday morning (the next day).At some point over the weekend the patient died.The caller did not know the exact date/time of death.At the time of the call, they did not have a chance to ask the physician what their opinion of the cause of the complication during the case on friday or the cause of death was.This case was not part of a clinical study.The bwi instruments used during the procedure were a smart touch surround flow ablation catheter (df curve), a soundstar catheter and patches.It was initially thought by the physician that the patient had a coronary spasm or inadvertently the ablation catheter went into a coronary cusp and caused transient st changes causing this adverse event.Intervention provided was nitroglycerin administration, echocardiogram was performed to rule out pericardial effusion, and heart catheterization/coronary angiogram.Echo and heart cath were said to be normal.Other relevant patient history: aortic valve replacement with bio prosthetic, coronary artery bypass surgery.A smartablate generator m490002 with serial number (b)(4) was used.The patients date of death was (b)(6) 2022.The physician said he did not know the cause of death.The details of death event provided by the physician were that the patient finished watching a basketball game on sunday afternoon and felt tired.He went and laid down in bed.After a little while the patient¿s spouse checked on him and he had passed away.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14137882
• MDR Text Key: 289467519
• Report Number: 2029046-2022-00836
• 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: Other
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; SOUNDSTAR CATHETER
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male