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

Catalog Number D132705

Device Problems Expiration Date Error (2528); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a redo atrial fibrillation (afib) case, along with a typical flutter (atrial flutter right) procedure with a thermocool® smart touch¿ bi-directional navigation catheter and an expired product was used on the patient issue occurred.Initially it was reported that the physician felt a steam pop while ablating.The steam pop occurred during the ablation of the flutter line.The physician requested an echo machine to check for an effusion.The physician moved to a different area to continue ablation.The surgery was delayed by 10 minutes.The surgery was completed successfully.No patient consequence.No other issues besides the steam pop was reported.Additional information was provided on 01-feb-2024.The catheter was expired and the lab manager was informed of this beforehand but decided to proceed with the procedure.They had no other issues with the catheter during the procedure and were able to complete many ablations successfully and treat the areas that needed to be treated.Additional information was provided on 15-feb-2024.It was believed that the product was received at the facility prior to the expiration date; however, not sure exactly when that catheter arrived.The product probably expired during storage.The smartablate generator was set to power control mode with the default cutoff values.It was not known the length of the ablation cycle when the pop was observed at the same tip position, but the physician had ablated in the same spot for multiple lesions because there was still an electrical connection there.Additional information was provided on 25-feb-2024.The device was owned by the clinic and not part of jnj consignment stock.Steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.Therefore, the steam pop reported was assessed as non mdr reportable.The expired product used on the patient issue was assessed as mdr reportable.

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 30661158m 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).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 18774954
• MDR Text Key: 337072436
• Report Number: 2029046-2024-00620
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Catalogue Number: D132705
• Device Lot Number: 30661158M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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: UNK_SMARTABLATE GENERATOR
• Patient Age: 43 YR
• Patient Sex: Female