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

Catalog Number D134701

Device Problem Obstruction of Flow (2423)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the ablation catheter could not be flushed.The ¿tubing set ventil upstream the catheter¿ was opened, and the flow was correct.As the ¿ventil was opened direction catheter¿, the flow was blocked.There was no error from the pump.Correct catheter settings were selected on the device.The catheter was changed, and the issue was resolved.No consequences for the patient and no delay.

Manufacturer Narrative

E 1.Initial reporter phone : (b)(6).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 biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the ablation catheter could not be flushed.The ¿tubing set ventil upstream the catheter¿ was opened, and the flow was correct.As the ¿ventil was opened direction catheter¿, the flow was blocked.There was no error from the pump.Correct catheter settings were selected on the device.The catheter was changed, and the issue was resolved.No consequences for the patient and no delay.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation and irrigation test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed no damage or anomalies on the device.An irrigation test was performed and during the analysis, the device was found occluded.Further investigation revealed that the irrigation tube was occluded by a white foreign material in the tip section.For this reason, a fourier transform infrared spectroscopy (ftir) analysis was requested, and it was determined that the unknown material was polyisobutylene (pib); however, the source of origin remains unknown.A manufacturing record evaluation was performed for the finished device 31088751l number, and no internal actions related to the reported complaint condition were identified.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.The irrigation issue reported by the customer was confirmed.The potential cause of the foreign material occluding the irrigation tube cannot be determined.The instructions for use (ifu) contain the following recommendations: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.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 UNI-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: 18963929
• MDR Text Key: 338773113
• Report Number: 2029046-2024-00989
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup,Followup
• Report Date: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134701
• Device Lot Number: 31088751L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/04/2024; Not provided
• Supplement Dates FDA Received: 05/01/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2023
• 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: UNK GENERATOR; UNK PUMP