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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Arrhythmia (1721)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

E 1.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).

Event Description

It was reported that a patient underwent a cardiac ablation and the patient experienced arrhythmia that required pacemaker implantation.First, it was reported that during fluoro-guided transeptal puncture performed with a non-biosense webster (bwi) needle ¿nor sheet¿, the ascending aorta was punctured.After a waiting time of 30 minutes, the electrocardiogram (ecg) and transesofageal echocardiography did not reveal any complication to the patient and the procedure was resumed.During the same procedure, while doing ablation of the posterior wall with pulsed field ablation (pfa boston scientific), the patient lost intrinsic electrical conduction.Sinus rhythm was lost but a junctional spontaneous rhythm recovered towards the end of the procedure.At the time, the physiological electrical conduction was lost.There were no biosense webster catheters present in the patient¿s body.Pacemaker implantation was planned.Additional information received indicated that a bwi ablation catheter was used and the adverse event was discovered during the use of bwi products.The physician's opinion on the cause of this adverse event was that it was procedure related.Patient has improved after extended hospitalization due to pacemaker implantation.

• 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: 19085861
• MDR Text Key: 339876505
• Report Number: 2029046-2024-01190
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2024
• 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; NON-BIOSENSE WEBSTER NEEDLE; SMARTABLATE GENERATOR KIT-WW
• Patient Outcome(s): Required Intervention; Hospitalization