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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 08/28/2023

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31049274l number, and no internal action related 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 a ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac perforation requiring a pericardiocentesis.Description of health problems was cardiac tamponade.After the procedure was completed, an endocardial echocardiogram confirmed the presence of effusion.As blood pressure was decreasing, drainage was performed.Timing was about 2.5 hours after the patient entered the room.Drainage was performed and a follow-up observation was made.Patient medical history and concomitant diseases - severe cardiac insufficiency (ef 17%).After implantable cardioverter defibrillator (icd) implantation, the lead was in ra and rv.Because of vt, the 1st session was performed.Since the patient had a recurrence, the patient was to attend this time for the 2nd session a week later.Atrial septal puncture was not performed.Ablation was performed before adverse event was identified.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting was 8ml/min.Standard setting as it was 30w.Bp 70/50 on entry; 40/30 after procedure; 100/60 after drainage.Method of cf monitoring was real time graph; dashboard; and vector.Coloring settings for visitag was tag index.Causal relationship with product was unknown.There were no abnormalities observed prior to and during use of the product.Additional information was received on 31-aug-2023.It was discovered post use of biosense webster products.Outcome of the adverse event was improved.Transseptal puncture was not performed.The event occurred after the ablation procedure completed.No error message was observed.Additional information was received on 04-sep-2023.Physician¿s opinion on the cause of this adverse event was the procedure.The physician commented that the perforation site was the left atrial appendage and the cause of the cardiac tamponade was not due to left ventricular target site ablation.Pericardial drainage was performed.After that, the perforated site was identified and was then surgically sutured.After drainage, open chest surgery was performed.The patient was under observation.No relevant tests / laboratory data.Visitag module was used, parameters for stability used was the recommended setting.Additional filter used with the visitag was accuresp.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.

• 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: 17765817
• MDR Text Key: 323627586
• Report Number: 2029046-2023-02107
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2023

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
• Device Lot Number: 31049274L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• 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: SOUNDSTAR ECO GE 8F CATHETER; UNK PUMP; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male