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

Model Number D134805

Device Problems Insufficient Cooling (1130); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/29/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 an unknown female patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.Temperature of smart touch sf catheter was high.Therefore, the physician confirmed by echo and tamponade was confirmed.This occurred about one hour after the start of the procedure.Pericardial drainage was performed after confirmation of tamponade.The patient was removed from the room.Atrial septal puncture was not performed.Ablation was performed before tamponade was identified.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting was 8 ml up to 30 w, 15 ml at 31 ~ 50 w.There is no comment by the physician particularly on the relationship with the product.No abnormalities were observed prior to use or during use of the product.The complaint product(s) will be returned for analysis.This adverse event was discovered during use of biosense webster products.The patient outcome of the adverse event is improved.No error message reported.High temperature is not mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On (b)(6) 2023, the product investigation was completed as the complaint device was not returned.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 30837157l 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.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15452424
• MDR Text Key: 300213684
• Report Number: 2029046-2022-02256
• 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: 06/22/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30837157L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female