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

Catalog Number D134805

Device Problem Obstruction of Flow (2423)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

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 flutter right (r-afl)) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and they were unable to flush the catheter.They found that they were unable to flush the catheter.To troubleshoot, they flushed the catheter on high flow with no resolution.Upon replacing the catheter, the issue was resolved, and the procedure continued.No adverse patient consequence was reported.Initially, the event was assessed as non mdr reportable.However, on 30-nov-2023, additional information was received which made the event reportable.On 30-nov-2023, it was reported that the physician had the catheter in the heart and pulled it to map with octaray.When he was flushing to go back up with the ablator, the issue occurred.The physician tried clearing the irrigation port with the syringe and tried disconnecting and reconnecting the syringe, but nothing would allow him to push fluid.A smartablate pump was used and there was no error from the pump.The correct catheter settings were selected on the generator and the pump was switching from ¿low¿ to ¿high¿ flow during ablation.Since the catheter was used on the patient, this event was assessed as mdr reportable with an awareness date of 30-nov-2023.

Manufacturer Narrative

It was reported that a patient underwent an atrial flutter right (r-afl)) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and they were unable to flush the catheter.They found that they were unable to flush the catheter.To troubleshoot, they flushed the catheter on high flow with no resolution.Upon replacing the catheter, the issue was resolved, and the procedure continued.No adverse patient consequence was reported.Initially, the event was assessed as non mdr reportable.However, on 30-nov-2023, additional information was received which made the event reportable.On 30-nov-2023, it was reported that the physician had the catheter in the heart and pulled it to map with octaray.When he was flushing to go back up with the ablator, the issue occurred.The physician tried clearing the irrigation port with the syringe and tried disconnecting and reconnecting the syringe, but nothing would allow him to push fluid.A smartablate pump was used and there was no error from the pump.The correct catheter settings were selected on the generator and the pump was switching from ¿low¿ to ¿high¿ flow during ablation.Since the catheter was used on the patient, this event was assessed as mdr reportable with an awareness date of 30-nov-2023.Device evaluation details: on 02-jan-2024, the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation and pump flow and pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed no anomalies or damage on the device.A pump flow and pressure gage test were performed, and an occlusion was detected.Further investigation revealed that the irrigation holes in the dome section were occluded with reddish material.A manufacturing record evaluation (mre) was performed for the finished device 31104703l number, and no internal actions related to the reported complaint condition were identified.Based on the completed mre, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.The foreign material observed blocking the irrigation holes could be related to the issue reported by the customer; therefore, the customer complaint was confirmed.It should be noted that product failure is multifactorial.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 BI-DIRECTIONAL NAVIGATION
• 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: 18410464
• MDR Text Key: 331925330
• Report Number: 2029046-2023-03101
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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: D134805
• Device Lot Number: 31104703L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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: UNK_OCTARAY NAV.; UNK_SMARTABLATE PUMP.