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 Failure/Congestive Heart Failure (4446)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

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 31038217l number, 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

During a clinical trial, it was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered heart failure, which required prolonged hospitalization.Patient received a cardiac index ablation on (b)(6) 2023 under conscious sedation.On (b)(6) 2023, patient experienced heart failure categorized as moderate and is considered a serious injury due to serious deterioration in the health of the subject as defined by prolonged hospitalization (admission date (b)(6) 2023 and discharged (b)(6) 2023).Relationship to study device is not related and relationship to primary study procedure is possible relationship to the index procedure.The adverse event is unexpected/unanticipated.The outcome is recovered/resolved.Intervention was medication.Bmi 24.4 kg.M2.

Manufacturer Narrative

In the 3500a initial under the d10.Concomitant medical products and therapy dates section, the agilis sheath was listed as it was reported as a concomitant product.Additional information was received on 05-jan-2024 inactivating the agilis sheath for this complaint.Therefore, it is no longer considered a concomitant product.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: 18452199
• MDR Text Key: 332262739
• Report Number: 2029046-2024-00068
• Device Sequence Number: 1
• Product Code: LPB
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 31038217L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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: AGILIS SHEATH; OCTA,LNG,48P,3-3-3-3-3,F-CURVE; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 74 KG