MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 3-3-3-3-3, F-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D160906

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 04/06/2023

Event Type  Death  

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.Note: field b2.Date of death was not provide therefore it was populated with (b)(6) 2023 since it was stated the event was (b)(6) 2023 and the patient passed away 24 hours later.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 patient underwent a ischemic ventricular tachycardia (isvt) ¿ left ablation procedure with a octaray, galaxy, 48p, 3-3-3-3-3, f-curve and the patient suffered cardiac arrest requiring surgical intervention and prolonged hospitalization and ultimately death.It was reported that after starting to map the left ventricle, the patient went into emd (electromechanical dissociation) and it was observed by intra-cardiac echo that there was no cardiac movement.A code was called and the patient was resuscitated successfully.An impella device was inserted and the patient was stabilized and transferred to the intensive care unit (icu).Additional information received indicates the adverse event was discovered during use of bwi products, ~1 minute after entering the left ventricle with the octraray.Physician¿s opinion on the cause of this adverse event is that it was patient condition related.Post cabg patient with low ejection fraction (ef).Patient was unstable.Intervention provided was that a code was called.Cardio pulmonary resuscitation (cpr) was administered followed by emergent impella.Patient underwent a stemi 8 hours post impella implant.Patient could not stabilize and condition worsened.Family signed dnr and the patient passed 24 hours later after initial code was called.Patient required extended hospitalization because of the adverse event as patient was transferred to icu before passing 24 hours later.

Manufacturer Narrative

It was reported that a patient underwent a ischemic ventricular tachycardia (isvt) ¿ left ablation procedure with a octaray, galaxy, 48p, 3-3-3-3-3, f-curve and the patient suffered cardiac arrest requiring surgical intervention and prolonged hospitalization and ultimately death.It was reported that after starting to map the left ventricle, the patient went into emd (electromechanical dissociation) and it was observed by intra-cardiac echo that there was no cardiac movement.A code was called and the patient was resuscitated successfully.An impella device was inserted and the patient was stabilized and transferred to the intensive care unit (icu).Patient required extended hospitalization because of the adverse event as patient was transferred to icu before passing 24 hours later.Device evaluation details: on 16-may-2023, the product was returned to biosense webster inc (bwi) for evaluation.The evaluation has been completed.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device 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.No malfunction was observed during the product analysis.The physician¿s opinion on the cause of this adverse event is that it was patient's condition: post-cabg patient with low ef.The patient was unstable the root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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 ref.# (b)(4).

• Brand Name: OCTARAY, GALAXY, 48P, 3-3-3-3-3, F-CURVE
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 16866010
• MDR Text Key: 314524175
• Report Number: 2029046-2023-00956
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021134
• UDI-Public: 10846835021134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• 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
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D160906
• Device Catalogue Number: D160906
• Device Lot Number: 30932702L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• 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: SMARTABLATE GENERATOR SPARE-US
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 113 KG