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 Problem Heart Block (4444)

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6) the device has been reported as discarded, 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 lot 31147295l and no internal actions 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 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 an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced complete heart block.It was 2nd study of atrial fibrillation, treatment was performed for reconnected pv and induced at.Patient with 1st degree av block.At was induced in both atria and the ablation was performed in each atrium.Additional pvi was also performed for the reconnection.At was induced near csos, his was confirmed on another map, and ablation was performed.At induction became impossible, but the patient originally had 1st degree av block, and ah complete block occurred during ablation near the csos which was three hours after insertion of the thermocool® smart touch® sf bi-directional navigation catheter.Just before discharge, bradycardia had been resolving, and the patient left the room with hr 60.The physician determined that there was a causal relationship between the health hazard and the product.The physician¿ comment on the relationship between the event and the product was that the patient had 1st degree av block from the time of entering the room.It is considered the patient originally had no av node and maintained av rhythm by slow pathway, and that the slow pathway was disconnected by ablation near the csos.There were no abnormalities observed before using the product or while using the product.Additional information was received.No pacemaker was required.No interventions were required.Patient improved.Confirmed increase in heart rate.No extended hospitalization was required.The patient was discharged from the hospital.

• 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: 18540693
• MDR Text Key: 333195898
• Report Number: 2029046-2024-00225
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: 31147295L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; CARTO3 EXTERNAL REFPATCH 6PACK; LASSO NAV 2515,22P SPLITHANDLE; OPTRELL, 48 ELECTRODES, D-F; SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE IRR TUBE SET; SOUNDSTAR ECO SMS 8F CATHETER; UNK_CARTO 3
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 65 KG