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 Tamponade (2226); Ischemic Heart Disease (2493)

Event Date 03/04/2022

Event Type  Injury  

Event Description

It was reported that a female patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade and st elevations requiring a pericardiocentesis and surgical intervention.Mapping was performed by introducing the thermocool® smart touch® sf bi-directional navigation catheter into the left ventricle (lv) beyond the cusp.The premature ventricular contractions (pvc) were originating from the left ventricular outflow tract (lvot).Twenty (20) minutes later st elevation was found in the precordial leads and st depression was found in the inferior leads.The patient¿s systolic blood pressure decreased to the 70- mmhg range.A coronary angiogram (cag) was performed immediately and no particular abnormalities were confirmed in the cag findings.An aorta (ao) imaging was performed, but no abnormal findings such as discrepancy were observed.A small effusion was checked with the sound star, but it did not seem to have increased.Shortly thereafter, the blood pressure increased and st elevation resolved and the procedure resumed.After that, mapping was resumed and the pvc disappeared with ablation at the earliest stage.Although the procedure completed without any complications, blood pressure decreased just before the patient returned to the room.Body surface echo showed effusion, but it was not a large amount and it was an amount that made the team worry whether it could be punctured.The physician commented that i recognize that this issue was not causally related to the thermocool® smart touch® sf bi-directional navigation catheter.Atrial septal puncture was not performed.Ablation was done before tamponade was identified and no steam pop was confirmed.Pericardiocentesis was performed.During the procedure, the patient was injured in the right ventricle (rv) and consulted with the cardiac surgeon.A thoracotomy was performed but the bleeding has stopped and the bleeding site was the hinge of the rv.The patient's current condition was recovering, and the patient was scheduled to be discharged from the general ward soon.The physician commented that irrigation catheter¿s flow rate setting were pre 1 second, post 1 second at 8ml/min, 31 w or more: 15 ml/min.That is the physician¿s opinion on the cause of this adverse event procedure and not related with the bwi product malfunction.The patient outcome of the adverse event was improved.The patient did not require extended hospitalization because of the adverse event.A smartablate generator was used during the procedure and no servicing was requested for this equipment.No error messages were observed on biosense webster equipment during the procedure.Force visualization features used included dashboard, vector and visitag with color options of tag index.

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a female patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade and st elevations requiring a pericardiocentesis and surgical intervention.Mapping was performed by introducing the thermocool® smart touch® sf bi-directional navigation catheter into the left ventricle (lv) beyond the cusp.The premature ventricular contractions (pvc) were originating from the left ventricular outflow tract (lvot).Twenty (20) minutes later st elevation was found in the precordial leads and st depression was found in the inferior leads.The patient¿s systolic blood pressure decreased to the 70- mmhg range.A coronary angiogram (cag) was performed immediately and no particular abnormalities were confirmed in the cag findings.An aorta (ao) imaging was performed, but no abnormal findings such as discrepancy were observed.A small effusion was checked with the sound star, but it did not seem to have increased.Shortly thereafter, the blood pressure increased and st elevation resolved and the procedure resumed.After that, mapping was resumed and the pvc disappeared with ablation at the earliest stage.Although the procedure completed without any complications, blood pressure decreased just before the patient returned to the room.Body surface echo showed effusion, but it was not a large amount and it was an amount that made the team worry whether it could be punctured.Device evaluation details: on 4-apr-2022, the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13969185
• MDR Text Key: 291488399
• Report Number: 2029046-2022-00690
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30689045L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• 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: CARTO 3 SYSTEM; SOUNDSTAR ECO GE 8F CATHETER; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening