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 Tamponade (2226)

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a ventricular tachycardia ablation with thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac tamponade that required pericardiocentesis.In the vt (ventricular tachycardia) procedure, after the substrate mapping was completed, pace mapping was performed in right ventricular outflow tract (rvot), and cardiac tamponade occurred during the rvot ablation.When fluoroscopy was checked at the beginning of the ablation, it was confirmed that the patient's cardiac motion became sluggish, so the ablation was stopped, and drainage was performed.After immediate echo confirmation and drainage, the bleeding subsided, and the patient was safely returned to the room.The procedure was then terminated, and the patient's prognosis is under observation.The physician believes the contact force (cf) may have been a little high because there was a little difficulty in raising the catheter to the rvot.Ablation was performed prior to the pericardial effusion was noted.No error messages observed on biosense webster equipment during the procedure.

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 number lot 31103990la 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 4-apr-2024, bwi received additional information regarding the event.The patient fully recovered.The patient did not require extended hospitalization.Transseptal puncture was not performed.No evidence of steam pop.Additionally, the a section patient information was updated with the age and gender.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: 19021558
• MDR Text Key: 339138937
• Report Number: 2029046-2024-01102
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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: D134805
• Device Lot Number: 31103990LA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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: OPTRELL, 36 ELECTRODES, D-F; SOUNDSTAR ECO GE 8F CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Male