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 Pneumonia (2011)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) cardiac ablation (atrial fibrillation) which included a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the patient experienced pneumonia that required treatment (unspecified) and prolonged hospitalization.The patient underwent an ablation (pvi) on march 1st and developed symptoms of pneumonia.There were no product defects or special phenomena were observed during the procedure and the relevance to the ablation procedure is being confirmed.No abnormalities were observed during or prior to the use of the product.Additional information was received.As of march 18, 2024, the patient had no change for the current condition, and still hospitalized and undergoing treatment.It is unknown about the treatment he/she is receiving.Length of hospitalization extended due to treatment.Expected discharge date was unknown at the time of reporting.There were no symptoms of esophageal fistula such as sputum or hematemesis.Also, there was no comment that the product was the cause.The cause is unknown.The physician did not comment that the product or the ablation was the cause.The stsf catheter was selected correctly and ablation at 45w was performed.There was no problem in switching irrigation flow rate.Parameter settings will be confirmed at the next visit.Ablation history near esophagus was available (12 ablations).Details of pneumonia: aspiration pneumonia.Past medical history included stomach cancer, post-gastrectomy.

Manufacturer Narrative

E1.Initial reporter phone: (b)(4).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).

Manufacturer Narrative

The device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation was performed for the finished device number lot 31104201l, and no internal action related to the complaint was found during the review.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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: 19067663
• MDR Text Key: 339671427
• Report Number: 2029046-2024-01162
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• 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: 31104201L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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: CARTO 3 SYSTEM (FOR JAPAN); OCTA,LNG,48P,3-3-3-3-3,D-CURVE; SMARTABLATE; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention