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

Catalog Number D134801

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/31/2023

Event Type  Death  

Manufacturer Narrative

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 31080068l number, and no internal action elated 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.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 that a patient underwent an atrial fibrillation ablation procedure that included a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac tamponade that required pericardiocentesis and prolonged hospitalization.About two and a half hours after the start of the procedure, pulmonary vein isolation (pvi) was performed without any problem.Pop occurred when cavotricuspid isthmus (cti) ablation was performed.Subsequently, blood pressure decreased to about 60 mmhg and effusion was confirmed by body surface echocardiography.Vasopressor was administered, pericardial drainage and pericardiography were performed.After the drainage, blood pressure rose to about 100 mmhg, and the patient left the room in a communicative state.The ablation was performed for pulsed electrical field (pef) and atrial flutter (afl).The patient had no history of other cardiac disease.Septal puncture was performed with a radiofrequency (rf) needle manufactured by japan lifeline co.Patient status improved; however, the patient was transferred to another hospital on (b)(6) 2023 because the bleeding did not stop.Therefore, the patient required extended hospitalization.During the ablation, the remote-control operator read out the base impedance and impedance change, and no significant impedance change was observed at the time of the pop.Irrigation flow rate was 1 second for both pre and post, and there was no problem with operation.Physician's judgment on health hazard is non-serious (moderate/minor).Contact force (cf) monitoring methods were real time graph, dashboard, vector, and visitag.Coloring setting for visitag was tag index.Additional filters for visitag was fot.The physician commented that the effusion occurred due to the steam pop during cti ablation.There were no abnormalities observed prior or during the use of the product.Ablation was performed prior to noting the pericardial effusion.Correct catheter settings were selected on the generator.The pump switched from low to high flow during the ablation.No error message was observed on bwi equipment during the procedure.Generator parameters: power control mode, power: 35-40w, ai: around 350-400, cf: 10-20g during ablation.When steam pop occurred, impedance was 160 ohms that was higher than the base impedance, and the ablation was performed based on the possibility of pouch.During ablation, cf was not varied and no significant rise or fall in impedance.Ablation was stopped due to impedance spike.The catheter tip was confirmed no adhered substances.The length of ablation cycle when the pop was observed at the same tip position was 33 seconds.

Manufacturer Narrative

B2.Date of death is unknown.Therefore, this field was left blank.Additional information was received on 15-nov-2023.It was reported that on (b)(6) 2023, the patient received pericardiocentesis for the cardiac tamponade that occurred.On (b)(6)2023, the bleeding did not stop, and the patient was transferred to another hospital.After that, if the patient's condition stabilized, the patient would return to the cardiovascular center within the period from (b)(6) 2018 to (b)(6) 2022.However, the patient could not return because his condition could not be stabilized due to disseminated intravascular coagulation (dic) and systemic infection.After that, the patient passed away on an unknown date.The approximate time of death was also unknown.Per the additional information received, b2.Is death has been updated.In addition, h 6.Health effect - impact code and h 6.Medical device problem code have been updated with death (f02) and adverse event without identified device or use problem (a24).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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17801235
• MDR Text Key: 324113825
• Report Number: 2029046-2023-02148
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134801
• Device Lot Number: 31080068L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2023
• 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: JAPAN LIFELINE RADIOFREQUENCY (RF) NEEDLE.; PENTARAY NAV ECO 7FR, D, 2-6-2.; SMARTABLATE GEN. KIT (JAPAN).; SOUNDSTAR ECO GE 8F CATHETER.; UNK_CARTO 3.
• Patient Outcome(s): Death; Required Intervention; Hospitalization; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 61 KG