MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number R7F282CT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Pneumothorax (2012)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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.A 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.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6) male ((b)(6)) patient underwent a ventricular tachycardia (v-tach) ablation procedure with a decanav electrophysiology catheter and the patient suffered a pneumothorax and cardiac arrest requiring a chest tube prolonged hospitalization.During a v-tach case, a pneumothorax was discovered.There were no visible signs on the patient, but anesthesia had a suspicion.The pneumothorax was confirmed by x-ray.They had just finished checking under x-ray when the patient coded.The team began doing compressions and the medical intervention also included inserting a chest tube.The patient was reported to be in stable condition.The physician did not think the injury was caused by any of the catheters.The patient was in bad shape going into the procedure and had been intubated since the 24th.There were three catheters in the body at the time of the injury.Intracardiac echocardiography (ice) catheter was in the right atrium, a quad catheter in the inferior vena cava (ivc) and a decanav catheter in the pericardial space.The patient has been intubated for at least 4 days prior and had documented heart failure.The physician¿s opinion on the cause of this adverse event is that it was patient condition related.It is believed that the complication occurred due to patient condition.Patient outcome of the adverse event was reported as fully recovered (no residual effects).The patient required extended hospitalization because of the adverse event, the patient was taken back to intensive care unit (icu) and soon transferred to a different hospital.Patient was in hospital for a long list of heart conditions.It is unsure if the patient¿s stay was extended or not due to underlying conditions.The procedure was aborted and potentially rescheduled.This event will be reported against the decanav electrophysiology catheter as it was located in the pericardial space when the event occurred.

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13583789
• MDR Text Key: 286946057
• Report Number: 2029046-2022-00362
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/23/2022
• 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: UNSPECIFIED ICE CATHETER; UNSPECIFIED QUAD CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 127 KG