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

Model Number D134805

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

Patient Problem Stroke/CVA (1770)

Event Date 08/12/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30830138l and no internal action related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2022-02145 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter).

Event Description

It was reported that a 68-year-old male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a two thermocool® smart touch® sf bi-directional navigation catheters and the patient suffered a cerebrovascular accident requiring prolonged hospitalization.The physician informed the biosense webster inc (bwi) representative that they believe the patient had a stroke.The bwi representative stated that the patient has left-sided paralysis which was discovered post-procedure.No known intervention was planned at this time.The bwi representative stated that it is standard to check the catheters every 30-45 minutes for char.There was mild char which was wiped away and flushed twice from the thermocool® smart touch® sf bi-directional navigation catheter (lot # 30793806l) and once from the thermocool® smart touch® sf bi-directional navigation catheters (lot #30830138l).No equipment errors or technical issues were present during the procedure.There was also nothing abnormal during the procedure.The pre and post-irrigation of the catheter were used during the procedure.The temperature and impedance were monitored during the procedure and all were in normal ranges.The bwi representative stated that there was no indication of anything being abnormal.The procedure was 9 hours, with 2 hours and 45 minutes of radiofrequency (rf).The adverse event was discovered post use of biosense webster products, post procedure when trying to arouse patient from general anesthesia.Physician unsure on the cause.He mentioned possible plaque from atherosclerotic arteries being dislodged from catheter movement through aorta.Also mentioned mild/moderate char that had to be wiped off ablation catheter tips on 3 separate occasions throughout procedure.The patient was sent to the intensive care unit (icu) post procedure.At that time of the call, the patient was awake with left sided paralysis, but there were no specifics on interventions available.It was reported there was evidence of char noted on the electrode tip during the procedure, however, no evidence of blood thrombus/clot during the procedure.The correct catheter settings were selected on the smartablate generator and the smartablate pump was switching from low to high flow during ablation.No error messages or product problems noted during procedure.There were no issues related to temperature and flow on the catheter.Power control mode with temp cut off at 40 degrees c was used.The noted temperature, impedance and power varied throughout normal ranges during procedure.The patient was anticoagulated but activated clotting time (act) specifics during procedure are unknown.There were some ablations greater than 60 sec/none greater than 120 sec.Average force less than 25 grams/no ablations above 40 grams.All irrigation at prescribed rates.The pre-ablation high setting was 15ml/min.Heparinized normal saline was used as irrigation fluid.Visitag module settings: respiration setting, stability range 2mm, stability time 5sec, force over time (fot) 10 g, & tag size 2.Respiratory gated with color options used prospectively of time.The patient has a history of cardiac sarcoidosis and coronary artery disease (cad).Additional information was later received indicating the symptoms of left-sided paralysis lasted approximately 10 days and then resolved.The patient still has some mental confusion and remain in the hospitalized as of (b)(6) 2022.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15375836
• MDR Text Key: 299454285
• Report Number: 2029046-2022-02146
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30830138L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; THMCL SMTCH SF BID, TC, F-J
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 68 YR
• Patient Sex: Male