MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number D134825IL

Device Problem Obstruction of Flow (2423)

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

Event Date 02/18/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the device was used on the patient with irrigation issues.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 21-feb-2024.The suspected device for the reported flow/irrigation issue was the catheter.The issue was noted during or after the device was used on patient.The correct catheter settings were selected on the generator.The pump was not switching from ¿low¿ to ¿high¿ flow during ablation.Additional information was received on 25-feb-2024.The generator was on manual mode.The system did not provide any error.The generator did not continue ablating.The irrigation issue was originally considered non-reportable, however, bwi became aware that the device was used on the patient on (b)(6) 2024 and have reassessed the event as reportable.The awareness date for the reportable event is (b)(6) 2024.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 14-mar-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.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ bi-directional navigation catheter approved under p030031/s053.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation 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 suspected device for the reported flow/irrigation issue was the catheter.The issue was noted during or after the device was used on patient.The device evaluation was completed on 01-apr-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and 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 pump and pressure gage test was performed, and the device was found occluded.Further investigation revealed reddish with a with material occluding the irrigation holes.For this reason, an energy dispersive spectroscopy (eds) analysis was requested.It was found that there is evidence of saline solution and human tissue or fluid.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Based on the information observed during the product analysis, the customer complaint was confirmed since saline solution and human tissue was found occluding the irrigation holes.The instructions for use contain the following recommendations: always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.Do not use the catheter without irrigation flow 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 CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 18909742
• MDR Text Key: 337746812
• Report Number: 2029046-2024-00848
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/23/2024

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: D134825IL
• Device Lot Number: 31137878L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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: SMARTABLATE PUMP KIT (CN).; UNK GENERATOR.