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 04/01/2024

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).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 number lot 31236579l 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.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 premature ventricular contraction ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac tamponade that required pericardiocentesis.The ablation was performed six times at right ventricular outflow tract - (rvot) for pvc procedure.The patient¿s blood pressure decreased after the ablation was completed, and effusion was confirmed by the echocardiogram.Nitroglycerin and protamine were administered, and drainage was performed.About 400 cc of pericardial fluid was withdrawn by the drainage, and the echocardiogram showed no effusion.The blood pressure was stable, and the patient left the room.The physician¿s comment on the relationship between the event and the product was the causality relationship was unknown.Atrial septal puncture was not performed.Ablation was performed before pericardial effusion or tamponade was identified.Steam pop was not confirmed.No abnormalities were observed before or during use of the product.Additional information was received on 04-apr-2024.Patient improved.No error messages observed on biosense webster equipment during the procedure.Additional information was received on 19-apr-2024.The physician's opinion on the adverse event was the procedure.The patient fully recovered.Hospitalization was extended by one day just to be safe.

• 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: 19187842
• MDR Text Key: 341114648
• Report Number: 2029046-2024-01369
• 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
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• 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: 31236579L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2024
• 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: SMARTABLATE GEN. KIT (JAPAN); UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male