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 Problem Cardiac Tamponade (2226)

Event Date 03/27/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial tachycardia ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced a complete cardiac tamponade that required pericardiocentesis.Ablation in right atrium (ra) for atrial tachycardia was conducted, and atrial tachycardia was terminated.During the waiting time, it was confirmed that the patient¿s blood pressure decreased.The event occurred about 3 hours and 30 minutes after thermocool® smart touch® sf bi-directional navigation catheter use, after ra ablation and during the waiting time.Before the end of the procedure, pericardial drainage was performed, and the patient's condition improved.The procedure was completed.Atrial septal puncture was performed with rf needle.Ablation was performed before pericardial effusion was confirmed.Steam pop was not confirmed.No abnormalities observed prior to or during use of the product.The physician's opinions on the relationship between the event and the product was since there was no excessive ablation, the cause may not be the ablation itself but the brockenbrough performed at the time of left atrium (la) mapping.It was a good thing the event was confirmed after the atrial tachycardia had been successfully treated by ablation.Additional information was received on 01-apr-2024.The outcome of the adverse event was improved.No errors observed on biosense webster equipment during the procedure.Additional information was received on 09-apr-2024.Patient fully recovered and did not require extended hospitalization.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).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).

Manufacturer Narrative

The investigation was completed on 30-apr-2024.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31215022l and no internal actions 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.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: 19149443
• MDR Text Key: 340674862
• Report Number: 2029046-2024-01312
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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: 31215022L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2024
• 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: UNK PUMP; UNK RF NEEDLE; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 43 KG