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

Catalog Number D134721IL

Device Problems Signal Artifact/Noise (1036); Coagulation in Device or Device Ingredient (1096)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an superventricular tachycardia (svt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the medical team reported char.The char on tip should be wiped off with gauze by the surgeon.It was a head end blockage and the medical team was unable to determine if there are any remaining scabs remaining in the catheter.The patient was anticoagulated during the procedure.The physician considered that the amount of char to be excessive.A second device was used to complete the operation.There was no adverse event reported on patient.Additionally, it was reported that during the operation, the signal interference noise was observed on either the intracardiac, body surface, or electrocardiogram channels.The exact part of the interference was not confirmed.No patient consequences were reported.

Manufacturer Narrative

On 20-feb-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an superventricular tachycardia (svt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the medical team reported char.The char on tip should be wiped off with gauze by the surgeon.It was a head end blockage and the medical team was unable to determine if there are any remaining scabs remaining in the catheter.The patient was anticoagulated during the procedure.The physician considered that the amount of char to be excessive.A second device was used to complete the operation.There was no adverse event reported on patient.Additionally, it was reported that during the operation, the signal interference noise was observed on either the intracardiac, body surface, or electrocardiogram channels.The exact part of the interference was not confirmed.Device evaluation details: the device was returned to biosense webster for evaluation.A visual inspection, pump, temperature, impedance and electrical test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed no damage or anomalies on the device.According to the photo provided by the customer, char/thrombus/clot was observed on the tip and noise was observed on the screen, however, during the visual inspection no char residues were observed.The temperature test was performed, and no issues were observed.A pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.No malfunctions were observed during the device analysis.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed for the finished device number lot 31137546l and no internal actions related to the complaint were found during the review.The char/thrombus/clot issue reported was confirmed based on the photo provided by the customer.Char is a physical phenomenon of rf (radiofrequency), it can be the normal result of the ablation process.In the other hand, the electrical 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 recommendation: ecg (electrocardiogram) noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.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® SF UNI-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: 18441224
• MDR Text Key: 331905898
• Report Number: 2029046-2024-00047
• 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
• 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: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134721IL
• Device Lot Number: 31137546L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2023
• 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: CARTO VISITAG MODULE.; UNSPECIFIED GENERATOR.