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 Problems Stenosis (2263); Thrombosis/Thrombus (4440); Heart Block (4444)

Event Date 01/12/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced thrombosis, av (atrioventricular) heart block, and coronary artery stenosis requiring surgical intervention and extended hospitalization.Patient was treated for atrial fibrillation (af) ablation.During the procedure, an occlusion of the circumflex coronary artery is observed.Lengthening of the surface ecg (electrocardiogram) and then avb (atrioventricular blocks) values after radiofrequency shots in the left atrium.Radiofrequency in the coronary sinus to block the mitral line likely facilitated this circumflex occlusion.The coronary angiography on the table showed the clogging of the circumflex coronary artery.Resumption of the patient's natural rhythm occurred after drug injection of a vasodilator.This coronary was dominant on the right coronary, resulting in an inferior st+ acute coronary syndrome with complete "bav" (atrioventricular heart block).This st+ and the bav were amended as soon as the circumflex was reperfusion.This reperfusion, which occurs at 35 minutes from the onset of occlusion, follows the passage of the angioplasty guide and thromboaspiration.The injection of nitrates did not make it possible to modify the diameter of the stenosis observed at the time of reperfusion.Coronary stent placement immediately.Good patient constants were noted at the end of the procedure.The patient went on post-operative surveillance.4 days after surgery, the patient was doing well with preserved left ventricular ejection fraction.The gesture took place without technical difficulty.No abnormal catheter values were noted on the generator.After re-analysis of pre-procedure x-ray images, physicians were more inclined to believe that adverse events were related to the patient's anatomy.No device malfunctions were reported.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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).

Manufacturer Narrative

On 14-feb-2024, the product investigation was completed as the complaint device was not returned and the manufacturing record evaluation was provided.A manufacturing record evaluation was performed for the finished device number lot 31173800l 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18636025
• MDR Text Key: 334491073
• Report Number: 2029046-2024-00387
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• 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: 31173800L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2023
• 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: SMARTABLATE GENERATOR.
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening