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

Model Number D132701

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Asystole (4442)

Event Date 06/07/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.The patient experienced an asystole requiring surgical intervention and prolonged hospitalization.It was reported that after the procedure, the patient went to ¿asystole: external pacing¿.Reason for asystole was unknown.The patient was fitted with temporary pacemaker and moved to ccu.A thermocool® smart touch¿ bi-directional navigation catheter was used with product d132701, lot number not available.The adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was patient condition related.Intervention provided was external pacing, temporary pacemaker.Outcome of the adverse event was improved.The patient required extended hospitalization because of the adverse event due to the need for permanent pacemaker.Relevant tests/laboratory data-after procedure, heart echo did not show any indication of tamponade.Other relevant history- patient was in bradycardia before procedure.Heart rate 35bmp.Generator used was a smartablate g4c-2688.Patches lot number was not available.

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.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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

Additional information was received on 30-aug-2023 and it was reported that the correct product code for this event is d134805.Therefore, the d 1.Brand name, d 4.Catalog ,and d 4.Unique identifier( udi) have been updated on this report.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: 17259420
• MDR Text Key: 318575667
• Report Number: 2029046-2023-01446
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D132701
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CARTO3 EXTERNAL REFPATCH 6PACK; SMARTABLATE GENERATOR KIT-WW
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female