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

Model Number D134805

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

Patient Problems Cardiac Tamponade (2226); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  Injury  

Event Description

It was reported that a female patient aged 74 years old underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention and prolonged hospitalization.Blood pressure decreased during conducting of left superior pulmonary vein (lspv) roof ablation.Echocardiography confirmed cardiac tamponade.Timing when complaints occurred was after about 3 hours after the start of the procedure.Blood pressure recovered after drainage.Although the procedure was continued, the leakage of blood accumulated in epi did not stop, and the procedure was discontinued.Surgery was performed.The ablation procedure itself was completed after treatment with pulmonary vein isolation plus (pvi) + at.Atrial septal puncture was performed by radiofrequency (rf) needle.Ablation was performed before tamponade was identified.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting was initial setting 30w or more 15ml/m.The physician's opinions on the relationship between the event and the product was that it was procedure related.The graph viewer of visitag, which may have caused tamponade, was reviewed: contract force (cf) at the final ablation had been exceeded 70 g.According to the physician, data was reviewed using the replay function.It was confirmed the moment when pentaray entered to left atrial appendage laa, and spine popped out.After that, blood pressure of the patient decreased from 140 to 60.Since it was confirmed that there was a hole in the laa during the surgical procedure, it is not 100% certain, but it is highly likely that tamponade occurred at this time.There were no abnormalities observed prior to and during use of the product.The complaint product(s) will not be returned for analysis.Generator make, model is smartablate generator, the serial number was unknown.Transseptal needle product was a rf needle.No error message was observed on biosense webster equipment during the procedure.The force visualization features used were real time graph; dashboard; vector; and visitag.Additional filter used with the visitag was fot.The color option used prospectively was tag index.The outcome of the adverse event was fully recovered.The patient required extended hospitalization because of the adverse event for treating tamponade.Correct catheter settings was selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.The pump flow rate was normally controlled by the generator.Parameters for stability used for the visitag module was range2.5mm/time3s/fot3g25%/tagsize2mm.

Manufacturer Narrative

Initial reporter phone: (b)(6).An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 30663238l 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was requested and on 21-nov-2022, a response was received and based on internal review and assessment, it was determined that this complaint is no longer reportable under the thermocool® smart touch® sf bi-directional navigation catheter(stsf) with manufacturer report number 2029046-2022-02711; however, it is now reportable under the pentaray nav high-density mapping eco catheter.Therefore, any additional information pertaining to this event will be reported under manufacturer report number 2029046-2022-03177.Since the event was reassessed as not reportable against the thermocool® smart touch® sf bi-directional navigation catheter(stsf), the h 6.Health effect - clinical code, h 6.Health effect - impact code, and h 6.Medical device problem code have been updated.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

Additional information was received on 03-nov-2022.It was reported that ¿ope also had a hole in the laa, it is not completely sure but it's highly likely that it was a tampo at this time.¿ clarification was requested regarding the statement of: ¿ope also had a hole in the laa", that was reported on 03-nov-2022.Additional information was received on 21-nov-2022.It was clarified that a perforation mark was found in the left atrial appendage (laa).It was also clarified that the spine popped out on visualization.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: 15719484
• MDR Text Key: 302920561
• Report Number: 2029046-2022-02711
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Followup
• Report Date: 12/19/2022

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 Expiration Date: 11/05/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30663238L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 11/03/2022
• Supplement Dates Manufacturer Received: 11/03/2022; 11/21/2022
• Supplement Dates FDA Received: 12/02/2022; 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2021
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER; UNK BRAND RADIOFREQUENCY NEEDLE; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female