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

Model Number D134804

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Pericardial Effusion (3271)

Event Date 12/20/2021

Event Type  Injury  

Event Description

It was reported that a male patient with a date of birth of (b)(6) underwent an atrial flutter ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a pericardial effusion which required extended hospitalization.During the procedure, the patient was on the table.The physician scrubbed in and diagnostic and therapeutic catheters inserted into the heart.They noticed a stop into radio frequency delivery from the smart ablate alert due to high impedance.We noticed a rapid high impedance curve on the monitor graph window.Next to this event, they noticed no change into the patient parameters.A few minutes later, they noticed a change in the patient¿s blood pressure than stabilized.A transthoracic echography was made.A small cardiac effusion had been noticed.They are not sure if it was there at the beginning.The patient will be hospitalized to make sure everything went back to normal.The physician¿s point of view: as the patient was under general anesthesia, had low ejection fraction and his fast arrhythmia stopped, the blood pressure dropped by this.The surgery was delayed 15 minutes due to the reported event.The procedure was successfully completed.Patient consequence was blood pressure drop.There were other medical interventions required, blood pressure dropped.Additional information was received on the event.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was the patient condition.Atrial flutter ablation was provided.The patient outcome of the adverse event was fully recovered.The patient did require extended hospitalization because of the adverse event to observe stable vital signs and stable effusion.Other relevant history steam pop sound heard during impedance fast raise up.Fast atrial arrythmia +/- 220 ms ef 10% hard drug user.Transseptal puncture was not performed.Prior to noting the pericardial effusion, ablation was not performed.There was evidence of a steam pop, there was sound and high impedance.The event occurred during ablation phase.An irrigated catheter was used in the event, the flow setting was 8 cc/min.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Force visualization features used was graph, dashboard, visitag and ftpi.The visitag module was used, parameters for stability used were 4mm, 3ms, 25% of 3g size 2mm.The additional filter used with the visitag was respiration gating.Color options used prospectively were ftpi.Additional information: generator information: smartablate system rf generator.Generator parameters power control mode with 30 watts, 40 celsius degrees and 250 ohms cut off with spike cut off of 50 onhms/0.5 sec and in cut off of 50 ohms.The noted temperature, impedance and power at the time of steam pop: temperature: min 26,4 max 31,8 avg 27,4; impedance: init 126 delta diminution 28.On graph viewer impedance raise up of +/- 30 ohms, power: min 4w max 31w avg 30w.The impedance cut-off value was not exceeded and not stopped.Able to stop the ablation when released foot off the pedal.No cut-off reached.Since the adverse event is life threatening and required prolonged hospitalization and may 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.The high impedance issue was assessed as not mdr reportable.Since the user-defined cut-off was not exceeded, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.

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).

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 13-jan-2022, noted a correction to the 3500a initial as the physician information was omitted.Therefore, updated e.Initial reporter section.

Manufacturer Narrative

Additional information was received on (b)(6)2022, providing the status of the device as discarded.Since the device has been reported as discarded, no product investigation can be performed and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30638250l 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).

• 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: 13256883
• MDR Text Key: 288099391
• Report Number: 2029046-2022-00092
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30638250L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2021
• 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: SMARTABLATE GENERATOR KIT-WW; UNKNOWN BRAND DIAGNOSTIC CATHETER; UNKNOWN BRAND PUMP; UNK_CARTO 3
• Patient Outcome(s): Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male