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 Cardiac Tamponade (2226)

Event Date 12/03/2021

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 reference number: (b)(4).

Event Description

It was reported that a male patient born (b)(6) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.Patient has a history of paroxysmal afib, also with typical atrial flutter.During the procedure, a pericardial effusion was noticed at the end of the case.The pericardial effusion was confirmed by a pre-effusion check with ultrasound with the ice catheter.The medical intervention provided was a pericardiocentesis and 300cc of fluid were removed and they pulled the drain.The patient was reported to be in stable condition.The physician stated abnormal anatomy and when ablating the ct line.The physician¿s opinion on the cause of this adverse event was the patient¿s unusual/abnormal anatomy, specifically in the right atrium and cavo-tricuspid isthmus, made it difficult to maintain his usual catheter stability when ablating in that area.Patient remained fully recovered with no residual effects.The patient required an overnight stay for observation post pericardiocentesis.He was dismissed the next day with no residual/remaining issues.The bayliss nrg transeptal needle (ref (b)(4)) was used.There was never evidence of a steam pop during the procedure.The pericardial effusion was not appreciated until the final/post intra-cardiac ultrasound imaging was obtained.The physician believed the acute event most likely occurred during ablation of the cti.Irrigated catheter was used in the event and the flow settings were 2ml/min for slow-flow and 15ml/min for high-flow.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.No error codes were observed during the procedure.Force visualization features used: the force graph, dashboard, and vector were all used throughout the case, as was the visitag module.Visitag settings were 2mm over 3 seconds, with an fot setting of 25% for 3 seconds.Visitag size used was 3mm with no additional filter used with the visitag.Color options used prospectively: visitag color bar range was specific to fti.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 27-dec-2021, noted a correction to the 3500 initial report as it was missing the physician information.Therefore, updated e.Initial reporter.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 12-jan-2022.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 male patient born (b)(6) 1949 underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.The device evaluation was completed on 31-jan-2022.The device was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all its features.Visual analysis of the returned device revealed that no damage or anomalies were observed on the smart touch sf (bidirectional).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.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.No malfunction was observed during the product analysis.The instructions 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.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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13091352
• MDR Text Key: 282813648
• Report Number: 2029046-2021-02257
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/17/2022

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: 01/05/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30653837L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 12/27/2021; 01/12/2022; 01/31/2022
• Supplement Dates FDA Received: 12/28/2021; 01/19/2022; 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2021
• 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: NON BWI- BAYLISS NRG TRANSEPTAL NEEDLE; SMARTABLATE GENERATOR KIT-US; UNKNOWN BRAND ICE CATHETER; UNKNOWN BRAND PUMP; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male