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 Thrombosis/Thrombus (4440)

Event Date 11/23/2021

Event Type  Death  

Event Description

It was reported that a male patient underwent an endocardial and epicardial ventricular tachycardia (vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered a thrombus requiring surgical intervention and the patient expired.It was reported that the patient was brought into the ep lab in normal fashion.Patient was prepped for endocardial and epicardial ventricular tachycardia ablation.The patient had a previous ventricular tachycardia (vt) ablation in (b)(6) 2021.A soundstar catheter was inserted first into the femoral vein and sound maps of the ventricles were created.Next, a stsf catheter was advanced into the femoral vein and into the right ventricle to map and ablate.Next, subxiphoid percutaneous epicardial access was obtained.A pentaray catheter was inserted into the pericardial space and the epicardium was mapped.Once the map was complete, the coronary arteries were tagged.Dye was injected into the coronaries and points were taken with the stsf, at the physician¿s request, when he saw an overlay between the catheter and the arteries on fluoroscopy.The physician then used carto to draw design lines on the epicardial fam map to denote where he thought the coronary arteries were located.Once the map was complete with tagged coronaries, a set of ablation lesions were created in areas of interest in the epicardium using the stsf catheter.Next the left ventricle was mapped.The physician advanced the stsf through femoral artery and reached the left ventricle using a retrograde aortic approach.A map of the left ventricle was created.The areas of interest were on the septum of the left ventricle and the catheter was unable to reach the area via retrograde, so the stsf was removed from the heart.A transeptal was then done.The stsf was advanced back into the femoral vein where it crossed into the left atrium from the transeptal and into the left ventricle.The left ventricle was mapped, and we were able to reach the septum.Ablation was done in areas of interest and the case was declared finished.All ablations were done using half normal saline.When the patient was being extubated, the blood pressure began to drop.Using the soundstar, we were able to visualize a clot in the right ventricle.Images and videos of this were saved onto carto.The patient was not able to be extubated and had to be taken into emergency cardiac surgery and the patient did not survive.There was no troubleshooting for any biosense webster inc.(bwi) products used during the case and the physician did not cite bwi product malfunction as the cause of the event/clot.Additional information was received on 07-dec-2021.The physician did not state an opinion on the cause of death and did not provide further details.The adverse event was discovered post use of bwi products.

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because 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.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).

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13031720
• MDR Text Key: 282481120
• Report Number: 2029046-2021-02215
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/17/2021
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GENERATOR KIT-WW; SOUNDSTAR ECO SMS 8F CATHETER; UNK_CARTO 3
• Patient Outcome(s): Death
• Patient Sex: Male