MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problems Device Alarm System (1012); Obstruction of Flow (2423)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2024.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.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 (afl) procedure with a thermocool® smart touch¿ electrophysiology catheter and an irrigation issue was noted while being used on the patient.Irrigation inadequate.During the procedure, there was an intermittent or low irrigation on the device but not complete occlusion.A second device was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received on (b)(6) 2024 stating that the device irrigation issue was noted during the device being used on the patient.The pump product information is unknown.The pump had a bubble error.To resolve the irrigation issue, the catheter was removed from the patient's body and refilled with water.Only one hole was found to have water flowing out.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.This irrigation issue was originally considered non-reportable, however, bwi became aware on (b)(6) 2024 that the irrigation issue was noted while being used on the patient and have reassessed the irrigation issue as reportable.The bubble error issue was assessed as non mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event was low.

Manufacturer Narrative

It was reported that a patient underwent an atrial flutter (afl) procedure with a thermocool® smart touch¿ electrophysiology catheter.Irrigation inadequate.During the procedure, there was an intermittent or low irrigation on the device but not complete occlusion.A second device was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received stating that the device irrigation issue was noted during the device being used on the patient.The pump product information is unknown.The pump had a bubble error.To resolve the irrigation issue, the catheter was removed from the patient's body and refilled with water.The device evaluation was completed on 28-feb-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation and pump and pressure gage test of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A pump and pressure gage test was performed and the device was irrigating correctly.No irrigation issues or bubbles errors were detected during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released 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¿ ELECTROPHYSIOLOGY 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: 18700615
• MDR Text Key: 336406294
• Report Number: 2029046-2024-00490
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133604IL
• Device Lot Number: 31168754M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2023
• 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.