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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bradycardia (1751)

Event Date 07/14/2022

Event Type  Injury  

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered bradycardia requiring implanting a temporary pacemaker.When the procedure was completed the patient had bradycardia which required a temporary pacemaker implantation.The patient with persistent atrial fibrillation developed a tendency toward bradycardia when pvi was successful and sinus rhythm returned.A catheter was placed in the atrium and ventricle, and the heart was gradually returned to sinus rhythm for observation.However, since the bradycardia was substantial, the temporary pacemaker was inserted.The patient returned to the hospital room after insertion of the temporary pacemaker and is being followed up.The patient was fully conscious and conversed without any problem except for the symptoms of bradycardia.The physician's opinions on the relationship between the event and the product, there was no problem with the product used, and it was used as usual, so it was not product-related.The af stopped in a patient with a weak pulse to begin with, which may have caused bradycardia for better or for worse.Treatment of af was successful.The temporary pacemaker was also successfully implanted, and the patient's condition is now stable.Additional information was received on the event.There was no extension of the hospitalization period.The physician¿s opinion on the cause of this adverse event was a patient condition.The physician considered that the cause of the adverse event was not related with biosense webster, inc.Products.The physician also commented that it was considered that the bradycardia occurred because af was stopped by the ablation procedure since the patient originally had a weak pulse.Temporary pacing was conducted.The patient outcome of the adverse event was improved.

Manufacturer Narrative

Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, 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 30739448l 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.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.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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15204750
• MDR Text Key: 297676457
• Report Number: 2029046-2022-01842
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2022

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 Expiration Date: 03/20/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30739448L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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
• Treatment: LASSO NAV 2515,22P SPLITHANDLE; SOUNDSTAR ECO GE 8F CATHETER; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Sex: Male