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 05/18/2021

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

[safety note update 2] it was reported that a (b)(6)-year-old, male, ((b)(6) kg) patient underwent a ventricular extrasystoles (ves) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and experienced a pericardial effusion with no intervention but required prolonged hospitalization.It was noted that this patient had a medical history of dilated cardiomyopathy (dcm) with ejection fraction 45%.During the procedure, the patient experienced a pericardial effusion (pe).The procedure was interrupted to check the amount of blood via ultrasound.The amount was very low and was not needed to be punctured.The procedure was cancelled after pe was noted so that the patient could be monitored.Physician did not say if the catheter caused the complication.The patient required extended hospitalization because of the adverse event due to an observation of spontaneous decline of the pericardial effusion.Prior to noting the pe, ablation was not performed and there was no evidence of a steam pop.The event occurred during the mapping phase.The patient was reported to have fully recovered (no residual effects).The information regarding prolonged hospitalization was received on (b)(6) 2021.Therefore, the awareness date for this reportable event is (b)(6) 2021.The physician¿s opinion on the cause of this adverse event was reported as: ¿from my point of view, the catheter is not suspected to be malfunctional.The pericardial effusion was probably caused during mapping via the ablation catheter.¿ the event was discovered during use of biosense webster products.A transseptal puncture was not performed.Force visualization features were used: dashboard, vector, visitag, the visitag module was used and the parameters for stability were used: 3 mm, 3sec, 25%, 3g.An irrigated catheter was used in the event and the flow setting: stsf with 8 and 15 ml/min.The correct catheter settings were selected on the generator.There were no error messages observed on biosense webster equipment during the procedure.Initially, it was reported on (b)(6) 2021 that the pump was switching from low to high flow during ablation.Additional information was received on (b)(6) 2021 and it was reported that the pump was not switching from low to high flow during ablation (no ablation done).

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation on 25-jun-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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a 73-year-old, male, (90kg) patient underwent a ventricular extrasystoles (ves) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and experienced a pericardial effusion with no intervention but required prolonged hospitalization.It was noted that this patient had a medical history of dilated cardiomyopathy (dcm) with ejection fraction 45%.During the procedure, the patient experienced a pericardial effusion (pe).The procedure was interrupted to check the amount of blood via ultrasound.The amount was very low and was not needed to be punctured.The procedure was cancelled after pe was noted so that the patient could be monitored.Physician did not say if the catheter caused the complication.The patient required extended hospitalization because of the adverse event due to an observation of spontaneous decline of the pericardial effusion.Prior to noting the pe, ablation was not performed and there was no evidence of a steam pop.The event occurred during the mapping phase.The patient was reported to have fully recovered (no residual effects).Device evaluation details: the device evaluation was completed on 10-aug-2021.Visual analysis of the returned sample 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 force, magnetic and temperature 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 (mre) was performed, and no internal actions related to the reported complaint condition were identified.Based on the mre, the d4.Lot, d4.Expiration date, and h4.Device manufacture date were updated.As part of biosense webster inc¿s quality process, all catheters are manufactured, inspected, and released to approved specifications.The root cause of the adverse event remains unknown.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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
• MDR Report Key: 12059812
• MDR Text Key: 263456835
• Report Number: 2029046-2021-00989
• 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: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30517878L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 90