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

Catalog Number D134801

Device Problems Obstruction of Flow (2423); High Readings (2459)

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

Event Date 02/01/2024

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and during ablating on the roof of the left atrium (la), an impedance was gradually increasing.When the stsf catheter was removed from the patient¿s body and was checked, the irrigation was defective.The catheter was flushed outside the patient¿s body.However, the catheter was not irrigating from the tip and so the catheter was replaced.The issue resolved and the procedure was completed without patient consequence.

Manufacturer Narrative

During an internal review on 04-apr-2024, it was noted that the code of high readings (a090807) was missing from the initial 3500a report mwr-02022024-0001566052.Therefore, h 6.Medical device problem code was updated on this report.Although this code is not considered mdr reportable, it was used to capture the event related to ¿impedance was gradually increasing¿.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

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: pc-(b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and during ablating on the roof of the left atrium (la), an impedance was gradually increasing.When the stsf catheter was removed from the patient¿s body and was checked, the irrigation was defective.The catheter was flushed outside the patient¿s body.However, the catheter was not irrigating from the tip and so the catheter was replaced.The issue resolved and the procedure was completed without patient consequence.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, temperature, impedance, 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.The temperature and impedance test were performed and no issues were observed.No temperature or impedance issues were found.A pump and pressure gage test were performed, and the device was found occluded.Further investigation revealed reddish material occluding the irrigation holes.A manufacturing record evaluation was performed for the finished device number lot 31170006l and no internal action related to the complaint was found during the review.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.Since reddish material was observed in the irrigation holes, this issue could be related to the irrigation and impedance issues reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the reddish material inside de dome could be related to the usage of the device during the procedure.The instructions for use (ifu) 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: 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: 18794241
• MDR Text Key: 337514149
• Report Number: 2029046-2024-00658
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 05/02/2024

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: D134801
• Device Lot Number: 31170006L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/08/2024; 04/04/2024; 04/08/2024
• Supplement Dates FDA Received: 03/12/2024; 04/05/2024; 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2023
• 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