MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D132705

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pleural Effusion (2010); Heart Block (4444)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported a patient underwent an idiopathic ventricular tachycardia (idvt) cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and patient experienced a heart block av and pleural effusion requiring intervention.During the final ablation at the tricuspid valve, the patient went into temporary 3rd degree heart block (noticed on body surface ecg), for which they received temporary pacing in the right ventricle (rv) with the ablation catheter.After a few minutes, the patient converted on their own to 2nd degree heart block for 30 to 60 minutes.After an hour the patient regained full conduction without pacing assistance.They will be hospitalized overnight for observation.In addition, it was also reported that when the indifferent electrode was connected to the ngen console, it was loose in the socket and made a rattling sound during radio frequency (rf) delivery.When the user pushed in the cable, the noise was reduced.There were no errors displayed on the generator.Additional information was received.Patient recovered from heart block but had a pleural effusion.For pleural effusion, the patient was sat up after complaining of chest pain.Echo performed.Stabilized, intubated and then moved to be held.The patient was fully recovered (no residual effects) for temporary heart block and improved for pleural effusion.For temporary heart block, kept for observation.For pleural effusion, kept over the weekend for observation.Scheduled for ct (cardiothoracic) surgery for the pleural effusion (evacuation of the interthorax (~2l blood).Physician's opinion on cause for the temporary heart block is a combination of patient condition (poor baseline av conduction) and procedure (ablation near anatomical slow pathway).Unknown cause of pleural effusion.No transseptal puncture performed and no evidence of steam pop.No cardiac perforation found.Correct settings selected and no error messages on equipment during the procedure.The pump was not switching from ¿low¿ to ¿high¿ flow during ablation.The noise on the ngen console was assessed as non mdr reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event was remote.The adverse event was assessed as mdr reportable under the thermocool® smart touch¿ bi-directional navigation catheter.

Manufacturer Narrative

Additional information was received on 02-mar-2024 clarifying information provided on the 3500a initial which stated, ¿the pump was not switching from ¿low¿ to ¿high¿ flow during ablation,¿ was provided in error.They should have stated, ¿yes, the pump was properly switching from low to high flow during ablation.There was no malfunction noted on pump during the procedure.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¿ 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18784577
• MDR Text Key: 336295224
• Report Number: 2029046-2024-00642
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NGEN RF GENERATOR, US.; UNK PUMP.; UNK_CARTO 3.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female