MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NR7TCSIY

Device Problems Device Contamination with Body Fluid (2317); Contamination /Decontamination Problem (2895)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and a foreign material was found on the catheter.It was reported that on the proximal end of the navistar® rmt thermocool® electrophysiology catheter tip, one of the nurses found a dark colored substance after retracting the catheter out of the patient.Unfortunately, that substance had been thrown away, but the remains of it can still be seen on the navistar® rmt thermocool® electrophysiology catheter.It surrounded the tip (ring-shape) and supposedly was either clotted blood or remnants from the agilis steerable sheath it went through.The event occurred intra-op.There were no patient consequences.No action was taken to resolve the issue as it was found out after the procedure.Additional information received indicated a st.Jude abbott, agilis steerable sheath, 8.5fr inner diameter was used during this case.The physician did not feel any resistance while introducing or retracting the catheter from the sheath.The foreign material was red/black colored, felt hard, shaped around the proximal ring of the tip.The issue was encountered at the end of the procedure, so ablation was performed before material was noted.The nurse removed the substance and reported the material may be related to char.There were no error messages.No issues related to temperature or flow on the catheter.Generator parameters were in power control mode, power cut off at 50w, temperature cutoff at 43.No spikes in temperature.Activated clotting time (act) of 300 was maintained throughout the case.The physician did not consider the char/coagulum/thrombus/clot to be excessive (based on their clinical experience).The physician did not consider the amount of char/coagulum/thrombus/clot observed caused a potential risk to this patient.The duration of ablation used was greater than 60 seconds and greater than 120 seconds because of the dragging with navistar® rmt thermocool® electrophysiology catheter.There were no ablations that used forced above 40 g for any extended periods of time, with navistar® rmt thermocool® electrophysiology catheter the maximum gram is 8.High flow was 20 ml/min.Pre-ablation high setting was 2 ml/min.Normal heparinized saline was used as the irrigation fluid.Carto visitag module was not used.

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

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: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and a foreign material was found on the catheter.It was reported that on the proximal end of the navistar® rmt thermocool® electrophysiology catheter tip, one of the nurses found a dark colored substance after retracting the catheter out of the patient.Unfortunately, that substance had been thrown away, but the remains of it can still be seen on the navistar® rmt thermocool® electrophysiology catheter.It surrounded the tip (ring-shape) and supposedly was either clotted blood or remnants from the agilis steerable sheath it went through.The event occurred intra-op.There were no patient consequences.No action was taken to resolve the issue as it was found out after the procedure.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection of the returned device.Visual analysis of the device revealed reddish material adhered to the device's tip.A microscopic examination was performed.The material observed can be assumably blood.Per the event description, it can be determined that the material found is char.Char is a physical phenomenon of radio-frequency; it can be the normal result of the ablation process; however, the instructions for use contain the following instruction: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and an increased risk for collateral damage.Biosense webster¿s quality process ensures 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).

Manufacturer Narrative

Manufacturer's ref.# (b)(4).On 11-jan-2023, it was determined this event was incorrectly assessed as mdr reportable as foreign material, however, information available indicated the matter was most likely char.Char is a physical phenomenon of radiofrequency ablation and can be a normal result of the ablation process.The presence of char does not by itself represent a serious injury, nor is it necessarily the result of a device malfunction.As such, char is not mdr reportable.

• Brand Name: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 15777850
• MDR Text Key: 307788987
• Report Number: 2029046-2022-02803
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P030031
• 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,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR7TCSIY
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 30827691M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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: AGILIS STEERABLE SHEATH; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW