MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	NR7TCS4YU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Heart Failure (2206)
Date of Event	05/31/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture record evaluation cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a female patient ((b)(6) lb) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure under general anesthesia using stereotaxis and a navi-star¿ rmt electrophysiology catheter and suffered cardiac arrest, heart failure and death.Patient was noted to have a rapid heart rate thought to be related to atrial arrhythmia.Plan was for an av node ablation and placement of a bi-ventricular pacemaker.Prior to planned procedure, it was discovered that the patient had in fact a slow ventricular tachycardia with more ventricular electrograms than atrial electrograms.After undergoing anesthesia, the patient converted to sinus rhythm.Decision was made to perform a bipolar map of the lv to look for regions of scar.There were no noted low voltage regions.Areas of double potentials were targeted.A small number of lesions were placed (approximately 10-15) and there was no evidence of impedance rise or product malfunction.Temperature was set at 45 degrees celsius.Procedure was completed, and patient was awakening from anesthesia.About one hour after the case was completed, the patient coded, and the blood pressure dropped.Bedside echocardiogram did not reveal any pericardial effusion.Multiple rounds of cardiopulmonary resuscitation (cpr) were administered, an unspecified medication was also administered, and the patient¿s blood pressure recovered.About 30-45 minutes later, the patient coded again.Echocardiogram was called back and again revealed no effusion though right ventricle was not moving properly.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition-related, the patient had been through a lot in the last 8 days of being in a slow vt storm and shocked 4 different occasions with multiple shocks in those settings.Patient passed away later that evening.Physician believed that patient may have suffered a myocardial infarction; however, the autopsy report revealed the death was due to right ventricle failure, most likely after being in vt for 8 days when anesthesia put her under for the procedure she went into normal sinus rhythm and her heart was finally able to rest and with the weakened right ventricle (rv) she went into flash pulmonary edema.

• Brand Name: NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8725234
• Report Number: 2029046-2019-03296
• Device Sequence Number: 19264885
• Product Code: LPB
• UDI-Device Identifier: 10846835008470
• UDI-Public: 10846835008470
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S9
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: NR7TCS4YU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; STEREOTAXIS
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 84