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 02/01/2024

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).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 31173573l 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac tamponade that required pericardiocentesis.Although there was no change in blood pressure, etc.During the procedure, the blood pressure did not rise during hemostasis after the procedure was completed.Echocardiography showed that pericardial fluid was accumulating.Drainage was performed, and the blood pressure recovered from 70 to 100 and stabilized, so the patient was placed in ccu for observation.Atrial septal puncture was performed by rf (radiofrequency) needle.Ablation was performed before pericardial effusion or tamponade was identified.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting was default setting for the thermocool® smart touch® sf bi-directional navigation catheter.No abnormalities before or during use of the product.The relationship with the product was not mentioned.The physician commented that, as a patient factor, thin elderly women might be more prone to cardiac tamponade.Physician's opinion on the cause of the adverse event was patient condition.Patient has improved.No error messages observed on biosense webster equipment during the procedure.The hospitalization was not prolonged.The patient was discharged because there were no problems found during follow-up in ccu.Discharge date is unknown.

Manufacturer Narrative

On 25-feb-2024, bwi received additional information indicating that the correct settings were selected on generator and no error messages on equipment during procedure.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: 18771161
• MDR Text Key: 336185707
• Report Number: 2029046-2024-00610
• Device Sequence Number: 1
• Product Code: LPB
• 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
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 31173573L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2023
• 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: NGEN GENERATOR.; OCTARAY CATHETER.; SOUNDSTAR CATHETER.; UNSPECIFIED RF NEEDLE.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 38 KG