MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number BN7TCFJ8L

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Pulmonary Edema (2020)

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 av node ablation with an ez steer¿ nav ds bi-directional electrophysiology catheter (lot number unknown) and the patient experienced pulmonary edema and cardiac arrest that required cpr, intubation, and hospitalization.First, it was reported that the carto 3 system was displaying noise on the distal ecg of the ez steer¿ nav ds bi-directional electrophysiology catheter (lot number 30961886m) when connected to the patient interface unit (piu).The noise was also seen on the recording system.The electrode was black on the carto 3 system.They reseated the connections with no resolution.They replaced the cable without resolution.The catheter was replaced with an ez steer¿ nav ds bi-directional electrophysiology catheter (lot number unknown) and the issue was resolved.The procedure was continued.It was also reported after the av node ablation case, the patient suffered a flash pulmonary edema.Anesthesia started having some issues with the patient when they noticed a drop in pulse ox.The physician was in the process of removing the catheters so no biosense webster, inc.(bwi) products were in the body at the time of the injury.About 3-5 minutes later, the anesthesiologist called a code and they could not find a pulse.The code team was called in.Code medications were given and they started compressions and intubated the patient.They were able to stabilize the patient and get the pulse back and patient was sent to the intensive care unit (icu).The physician believed the injury was anesthesia related and not due to the ablation.It was also reported that the green patch cables were damaged during the commotion of the adverse event.The green patch cable was bunched up at the sensor connector where it plugs into the patch.The cable was starting to rip from being pulled off the patient.Tried connecting the green patch cable afterward and they got an error 1006, back patch sensor error.Additional information was received.Physician's opinion on the cause of this adverse event was the patient was having pre-existing health issues, leading to patient having ¿flash pulmonary edema¿.In the physician¿s words it was ¿directly related to anesthesia¿ and not our product or ablation.Patient improved.Patient was already an inpatient in the hospital.However, the patient was admitted to the icu after the event.The reported issues of noise, the electrode black on the carto 3 system and the cable damaged were assessed as non mdr reportable.The adverse event was assessed as mdr reportable.

Manufacturer Narrative

Additional information was received 18-feb-2024 stating a pump was not used.The physician used a 4mm ablation catheter.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) correction to the 3500a follow-up #1 was received on 05-apr-2024.In the 3500a follow-up #1 it was stated, ¿the physician used a 4mm ablation catheter.¿ clarification was requested as the device reported was a ez steer¿ nav ds bi-directional electrophysiology catheter/ bn7tcfj8l.It was clarified that they thought it was a 4mm catheter; however, could be mistaken.

• Brand Name: EZ STEER¿ NAV DS BI-DIRECTIONAL 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: 18686627
• MDR Text Key: 335196198
• Report Number: 2029046-2024-00460
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010068/S6
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BN7TCFJ8L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 8MM NAVIGATIONAL BI-DIRECT. JF; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; UNK CABLE; UNK RECORDING SYSTEM
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female