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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pericardial Effusion (3271)

Event Date 07/09/2021

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.A manufacturing record evaluation was performed for the finished device 30560372m number, and no internal action related to the complaint was found during the review.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 underwent a premature ventricular tachycardia (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.During a pvc procedure, a steam pop occurred while on rf in the rvot.The impedance spiked as the rf was turned off.A pericardial effusion was diagnosed via soundstar catheter after the patient's pressure dropped.A pericardiocentesis was performed by the physician removing 225 cc of fluid.The patient was stable at the time of the call.Additional information: this adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event: procedure.Intervention provided: ice, transthoracic uls, flouroscopy, pericardiocentesis.Patient was reported as fully recovered.The patient did not require extended hospitalization because of the adverse event.Generator parameters and thresholds: 45 w power control mode.The noted temperature, impedance and power at the time of steam pop were 23 degrees, 45 watts, 110-91 impedance.A transseptal puncture was not performed.Prior to noting the ct ablation was performed.The event occurred during ablation.Irrigated catheter was used in the event and the flow setting: default stsf settings.The correct catheter settings were selected on the generator.The pump was switching from low to high flow during ablation.No error messages observed on biosense webster equipment during the procedure.Force visualization features used: graph, dashboard, vector and visitag with visitag module parameters for stability: 3mm 3sec, 3g, 5 s and additional filter used: respiration.Steam pop is not mdr-reportable.High impedance is not mdr-reportable.Since the event is life threatening and required intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

• 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: 12269849
• MDR Text Key: 264834532
• Report Number: 2029046-2021-01249
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: Other
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30560372M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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: CARTO 3 SYSTEM; SMARTABLATE GENERATOR; SOUNDSTAR ECO; VISITAG MODULE
• Patient Outcome(s): Life Threatening; Required Intervention