WEBSTER

Description of Event or Problem

It was reported that a patient underwent an Electrophysiology (EP) study with a DECANAV catheter and a WEBSTER quad catheter and the patient experienced ventricular tachycardia (VT) / cardiac arrest that required defibrillation, cardiopulmonary resuscitation (CPR) and an impella placement. The patient¿s outcome was death.The DECANAV catheter, WEBSTER quad catheter, and WEBSTER HIS catheter were advanced to the patient's ventricle to begin pacing the ventricle. The patient went into ventricular tachycardia and the anesthesia team reported that the patient had no pulse. Multiple defibrillations were performed on the patient. CPR was provided, including compressions. An Impella was placed in the patient. After speaking with the patient's family, a DNR (do not resuscitate) was issued. No ablation was performed.Additional information was received. Only the coronary sinus (CS) catheter (DECANAV) was in the CS and a WEBSTER quad catheter was placed in the right ventricle (RV). Pacing was done to attempt to induce an arrhythmia as the patient was being tested for a potential supraventricular tachycardia that was causing inappropriate shocks on their Implantable Cardioverter-Defibrillator (ICD). This is when the patient went into VT. The patient did not have a pericardial effusion or any complication relating to Biosense Webster, Inc. (BWI) catheters. It was stated during the procedure that the patient would likely not survive. The physician's opinion on the cause of the adverse event was that the patient had a very low Ejection Fraction (EF) (below 20%) and went into VT, and was reported to not have a pulse once in VT. The physician stated the reason for the outcome was the patient was already sick and anesthesia could have played a role in them decompensating.Attempts have been made to obtain clarification of this complaint. However, no further information has been made available.The adverse event was assessed as MDR reportable under both the DECANAV catheter and WEBSTER quad catheter.

Additional Manufacturer Narrative

D4. Catalog: UNK_C3 WEBSTER QUADRAPOLAR WITH AUTO ID - FIXED.D4: UDI: As the catalog/model number was not provided, the (01)GTIN is not available.An Analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product Identification number was not provided to complete the evaluation. As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications. Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition. If the product is received at a later date, the investigation will be updated as applicable.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).