MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number NS7TCDL174HS

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) cardiac ablation procedure with a navistar¿ electrophysiology catheter and the patient experienced a complete heart block that required intervention.In addition, a thrombus/clot was noted on the tip of the catheter.Steam-pop occurred during the procedure, slow pathway ablation.The steam-pop- occurred during second radio frequency (rf) application, target power and temperature were 30w and 55c.During the ablation, the power was titrated and delivered between 20 to 30 watts only.Suddenly the physician felt and heard a pop and stopped the ablation.The impedance and temperature raised at that same moment.The patient had a complete av conduction block and needed immediately to be stimulated with a catheter into the ventricle.This took around 8 seconds.The av conduction restored within the next 2-3 minutes and remained so until the end of the procedure.Transthoracic echocardiogram (tte) was performed with no impact was noted by the physician.Procedure successfully completed.A thrombus/clot and char were noted on the tip of the catheter.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The char was assessed as non mdr reportable.Char is a physical phenomenon of rf energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.The thrombus/clot was assessed as a mdr reportable malfunction.The adverse event was assessed as a mdr reportable serious injury.It required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) cardiac ablation procedure with a navistar¿ electrophysiology catheter and the patient experienced a complete heart block that required intervention.In addition, a thrombus/clot was noted on the tip of the catheter.Steam-pop occurred during the procedure, slow pathway ablation.The steam-pop- occurred during second radio frequency (rf) application, target power and temperature were 30w and 55c.During the ablation, the power was titrated and delivered between 20 to 30 watts only.Suddenly the physician felt and heard a pop and stopped the ablation.The impedance and temperature raised at that same moment.The patient had a complete av conduction block and needed immediately to be stimulated with a catheter into the ventricle.This took around 8 seconds.The av conduction restored within the next 2-3 minutes and remained so until the end of the procedure.Transthoracic echocardiogram (tte) was performed with no impact was noted by the physician.Procedure successfully completed.A thrombus/clot and char were noted on the tip of the catheter.The device evaluation was completed on 13-apr-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.The device was visually inspected, and char/thrombus/clot attached on the device's tip was observed.The temperature test was performed, and no issues were observed.The other features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The root cause of the adverse event remains unknown.The steam pop 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.In the other hand the char and thrombus/ clot issues were confirmed.The instruction for use (ifu) contain the following warning and precautions: when using the catheter with conventional systems (using fluoroscopy to determine catheter tip location), or with the carto¿ 3 system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Do not use excessive force to advance or withdraw the catheter when resistance is encountered.The firmness of the braided tip dictates that care must be taken to prevent perforation of the heart.In relation with the char/thrombus/clot issue reported by the customer, the instruction for use (ifu) contain the following warning and precautions: before initiating the application of rf energy, a decrease in electrode temperature confirms the onset of saline irrigation of the ablation electrode.Monitoring the temperature from the electrode during the application of rf energy ensures that the irrigation flow rate is being maintained.Monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.If the temperature increases to 50°c during rf application, power delivery should be interrupted.Recheck the irrigation system prior to restarting rf application char is a physical phenomenon of rf, it can be the normal result of the ablation process.In addition, the catheter used in conjunction with an rf generator is capable of delivering significant electrical power.Patient or operator injury can result from improper handling of the catheter and indifferent electrode, particularly when operating the catheter.If during ablation, temperature does not rise, discontinue delivery of energy and check setup.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.Explanation of codes: investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿adverse event¿ and ¿steam pop¿.Investigation findings: contamination of environment by device (c1503) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported ¿char¿ issue.Investigation findings: problem due to thrombosis activation (c010604) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported ¿thrombus / clot¿ issue.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: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: 18750537
• MDR Text Key: 335894625
• Report Number: 2029046-2024-00571
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: 10846835000597
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P990025
• 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,Followup
• Report Date: 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 31195119M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/27/2024; 04/13/2024
• Supplement Dates FDA Received: 03/04/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2023
• 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_NGEN RF GENERATOR.
• Patient Outcome(s): Required Intervention