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 11/30/2021

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 patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis and prolonged hospitalization.It was reported that the patient suffered pericardial effusion/ tamponade and required pericardial puncture for drainage of blood.The reporter stated that it was probably due to patient movement/coughing.The surgery was not delayed due to the reported event.The procedure was successfully completed.No fragments were generated.Additional information was received on (b)(6) 2021.It was reported that this adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that this was patient condition related.The patient outcome of the adverse event was reported as improved.The patient required extended hospitalization to be monitored.Force visualization features used were dashboard and vector.The visitag module was used and the parameters for stability used were 3s; 3mm; 25%; 3g.Color option used prospectively was ablation index.A transseptal puncture was performed.Prior to noting the ct, ablation was performed.There was no evidence of a steam pop.It is unknown at what phase the event occurred (i.E., transseptal phase, mapping phase or ablation phase).It was realized when ablation was finished.An irrigated catheter was used in the event, the flow setting was 8ml/min up to 30w, 15ml above 30w.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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 patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis and prolonged hospitalization.It was reported that the patient suffered pericardial effusion/tamponade and required pericardial puncture for drainage of blood.The reporter stated that it was probably due to patient movement/coughing.The surgery was not delayed due to the reported event.The procedure was successfully completed.No fragments were generated.Device evaluation details: the device was returned to biosense webster for evaluation.A visual inspection, deflection, magnetic sensor functionality, screening, temperature and impedance, cool flow pump, patency, and ecg tests of the returned device were performed in accordance with bwi procedures.The thermocool® smart touch® sf bi-directional navigation catheter device was visually inspected, and it was found in good condition.The magnetic, temperature, and force features were tested, and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The issue reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation was performed for the finished device 30629207l, and no internal action was found during the review.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 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: 13101645
• MDR Text Key: 286067133
• Report Number: 2029046-2021-02259
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2022

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: 09/14/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30629207L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/13/2022; 02/25/2022
• Supplement Dates FDA Received: 02/07/2022; 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• 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: ABBOTT BRK TRANSSEPTAL NEEDLE.; SMARTABLATE GENERATOR KIT-WW.; UNK_CARTO 3.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention