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

Catalog Number D133604IL

Device Problem Obstruction of Flow (2423)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, 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 31169153m 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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter and an irrigation issue occurred during use on the patient.Occlusion/ no irrigation.It was reported that during the procedure, the device (including port, luer hub) was not irrigating.A second device was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received on 22-jan-2024.The issue was discovered during use on the patient.No error was noted on the pump.The temperature was high frequently during ablation and it could not be sprayed when the large head was withdrawn for extracorporeal scouring and cooling.Steps taken to resolve the irrigation issue was first to wash the three-way so the air end can go up.The flow rate proved not to be the cause of the pump.Wiped the large tip with gauze.Correct catheter settings were selected on the generator.This event was originally considered non-reportable, however, bwi became aware that the irrigation issue occurred during use on the patient on 22-jan-2024 and have reassessed the event as reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter.Occlusion/ no irrigation.It was reported that during the procedure, the device (including port, luer hub) was not irrigating.A second device was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received.The issue was discovered during use on the patient.No error was noted on the pump.The temperature was high frequently during ablation and it could not be sprayed when the large head was withdrawn for extracorporeal scouring and cooling.Steps taken to resolve the irrigation issue was first to wash the three-way so the air end can go up.The flow rate proved not to be the cause of the pump.Wiped the large tip with gauze.Correct catheter settings were selected on the generator.The bwi product analysis lab received the device for evaluation on 12-mar-2024.The device evaluation was completed on 19-mar-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and flow pump and pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A flow pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.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.The instructions for use contain the following recommendations: flush the catheter with heparinized saline prior to insertion into the body.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: 18705313
• MDR Text Key: 336298627
• Report Number: 2029046-2024-00498
• 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: 03/24/2024

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: D133604IL
• Device Lot Number: 31169153M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2023
• 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.