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

Catalog Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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 31049385l number, 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 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.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a cardiac arrest and cardiac tamponade requiring a pericardiocentesis.It was reported that they approached from left ventricular to premature ventricular contraction (pvc)s of right ventricular outflow tract origin (approximately 120 minutes after the start of the procedure and 60 minutes after the initial ablation).The patient complained of chest pain during left ventricular wall ablation.Heart rate was maintained, but blood pressure decreased, and consciousness was impaired.According to ekg ii.Avf, there was a finding of st depression.Emergency treatment such as cardiac massage and administering a vasopressor were performed, and the vitals returned stable.Then coronary angiography was performed without any problems.Finally, the patient was found to have cardiac tamponade by echocardiography.Necessary intervention such as pericardial cardiac drainage etc.Was performed and the patient returned to the ward.Vitals recovered to normal.Heart rate, blood pressure, and spo2 were all normal.The patient returned to the ward in a clear and communicative state of consciousness.The patient¿s outcome from the adverse event was reported as improved.The physician assessment of the health hazard was that it was serious and causally related to the product.Per the physician, we did not know the cause of this event, which occurred despite the fact that the same method was used to ablate only those areas (ventricular walls) where ablation would not cause a problem.During the ablation, there was no abnormalities or discomfort.There were no abnormalities observed prior to and during use of the product.Atrial septal puncture was not performed.The adverse event was discovered during use of biosense webster products and ablation had already been performed before cardiac tamponade was confirmed.Steam pop was not confirmed.The correct catheter settings selected on the smartablate generator in a standard setting and flow rate setting was low flow 2ml/min,~30w 8ml/min, 31w 15ml/min.The pump switching from ¿low¿ to ¿high¿ flow during ablation.Method of contact force monitoring included real time graph; dashboard; vector and visitag.Coloring settings for visitag included tag index.Visitag additional filters were force over time (fot).No error messages observed on biosense webster equipment during the procedure.

• 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: 17643363
• MDR Text Key: 322193304
• Report Number: 2029046-2023-01915
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2023

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: D134801
• Device Lot Number: 31049385L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2023
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM,; 8.5F SHEATH WITH CURVE VIZ SMC; CARTO 3 SYSTEM; SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO GE 8F CATHETER; UNKNOWN PUMP
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female