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

Catalog Number D134805

Device Problems Device Contamination with Body Fluid (2317); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 08/03/2023

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.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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.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 an atrial fibrillation ablation procedure that included thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced a cerebrovascular accident that required prolonged hospitalization.Timing of adverse event: about an hour after ablation procedure, post use of bwi products.Description of health hazard: after the ablation procedure, there was a "code stroke" called for the patient, about an hour after the procedure.The patient's status is unknown.About 5 minutes into ablation, there were impedance spikes noted.Generator settings were checked and the 4mm catheter setting had been selected.Low flow of 2 ml/min was running the whole time.The ablation catheter was removed and char was noted- the char was cleaned, the catheter was flushed on high, and the catheter was reinserted to continue the procedure with the appropriate sf catheter generator setting (irrigation 8/15 ml/min).Md thought that maybe the difficulty level of the procedure was a factor.Patient required extended hospitalization due to adverse event.Transseptal puncture was performed.No evidence of steam pop.No error messages observed on bwi equipment during the procedure.Impedance cut off value was exceeded during the procedure, the system stopped the ablation when the cut-off value was exceeded.Impedance would jump from 110 to 160 plus.Initially the generator was on default 4mm temperature control mode.Within 5 minutes we noticed the impedance spiking and switched to system to default stsf settings.Char was located on the tip of the electrode.The physician did not see any product problem, no system error messages presented by the system.Patient was anticoagulated and act (activated clotting time) was maintained above 300.The physician did not consider the char to be excessive.The physician thought the amount of char is potentially a risk to the patient but not convinced.No the pump did not switch from "low" to "high" flow during ablation for the first few minutes of ablation on temperature control mode.The pump was set to low flow 2 ml/min.The duration of ablation was not greater than 60 seconds.The average contact force was not greater than 40 grams.No ablations that used forced above 40 g for any extended periods of time.Heparinized normal saline used as the irrigation fluid.Respiration setting, stability range, stability time, force over time, & tag size: gated, 2mm, 3s, 25% 3g 3mm tag size.Color options used: tag index.No intervention provided to the patient.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.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17671184
• MDR Text Key: 322516606
• Report Number: 2029046-2023-01981
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2023

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 Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 09/01/2023
• 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: CARTO 3 SYSTEM; CARTO VISITAG MODULE; DECANAV CATHETER; OCTARAY CATHETER; SMARTABLATE GENERATOR; SMARTABLATE PUMP; SOUNDSTAR 10F CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization