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 Problem Pericardial Effusion (3271)

Event Date 05/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a (b)(6) year-old female (150lbs) patient underwent a premature ventricular contraction (pvc)/ idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a pericardial effusion (pe) which required extended hospitalization.During an pvc/ventricular tachycardia idiopathic case, a "trivial" pericardial effusion was noticed.The pericardial effusion was discovered by intracardiac echocardiography (ice).The pericardial effusion was confirmed by transthoracic echo.No medical intervention was provided.The patient was reported to be in stable condition.The procedure was aborted and not completed.Additional information received indicated the issue was discovered during use of biosense webster inc.(bwi) products in the mapping phase.A trans thoracic echo was performed and determined the effusion was not large enough to put a tube in for drainage.The patient required 2 extra days of extended hospitalization because of the adverse event.Transseptal puncture was not performed.Prior to noting the pe, ablation had not been performed.There was no evidence of a steam pop.Irrigation for the catheter was in a flow setting of 2ml/min.The correct catheter settings were selected on the generator and the pump switching from low to high flow during ablation, however, they did not burn.No error messages observed on biosense webster equipment during the procedure.Force visualization features used were dashboard and vector.The physician¿s opinion on the cause of this adverse event is that it was procedure related as the patient movement during the procedure potentially caused a small perforation from the ablation catheter free wall rvot.The patient was reported as fully recovered.

Manufacturer Narrative

The bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 56-year-old female (150lbs) patient underwent a premature ventricular contraction (pvc)/ idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a pericardial effusion (pe) which required extended hospitalization.The physician¿s opinion on the cause of this adverse event is that it was procedure related as the patient movement during the procedure potentially caused a small perforation from the ablation catheter free wall rvot.The patient was reported as fully recovered.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and an evaluation of all features of the device.Visual analysis of the returned product revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.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.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instructions for use (ifu) 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.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
• MDR Report Key: 11899363
• MDR Text Key: 257153870
• Report Number: 2029046-2021-00851
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30513960M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 68