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

Catalog Number D134805

Device Problems High Readings (2459); Contamination /Decontamination Problem (2895)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a foreign material described as white rubbery glue-like substance came out of the holes.It was reported by the caller that during a procedure, the caller reported they had a foreign substance seeping out of the catheter.The caller reported that when they finished ablating with the catheter, the catheter was pulled out of the body, and when it was quickly fast flushed, a white rubbery glue-like substance came out of the holes.There was no issue maneuvering the catheter.To troubleshoot the catheter was replaced, the issue was resolved, and the procedure was continued.There was no patient consequence.

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 26-mar-2024, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a foreign material described as white rubbery glue-like substance came out of the holes.It was reported by the caller that during a procedure, the caller reported they had a foreign substance seeping out of the catheter.The caller reported that when they finished ablating with the catheter, the catheter was pulled out of the body, and when it was quickly fast flushed, a white rubbery glue-like substance came out of the holes.There was no issue maneuvering the catheter.To troubleshoot the catheter was replaced, the issue was resolved, and the procedure was continued.There was no patient consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation was completed.Visual inspection, temperature, impedance, pump and pressure gage tests of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a white foreign material attached to the dome of the device occluding some of the irrigation holes.The temperature and impedance test were performed and the device was found working correctly.No temperature or impedance issues were observed.Afterward, a pump and pressure gage test were performed and an occlusion was detected.Due to the condition observed in the dome, a fourier-transform infrared spectroscopy (ftir) analysis was performed and it was determined that the material was primarily composed of a biological-base material, presumably a tissue.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The foreign material and high impedance issues reported by the customer were confirmed since the tissue was observed occluding some of the irrigation holes in the dome causing an increase in the impedance values.The potential cause of the material observed could not be determined.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 18909717
• MDR Text Key: 337756432
• Report Number: 2029046-2024-00846
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 31226501L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2024
• 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: MERIT MEDICAL PRELUDE SNAP, 9FR SHEATH.