MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER; SIMILAR DEVICE SNDSTR10, 510K # K070242

Model Number M-5723-00

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Death (1802); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 05/04/2017

Event Type  Death  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: carto 3 system (model# m-4800-01 serial# (b)(4)).Smartablate generator (model# m-4900-07 serial# (b)(4)).Smartablate pump (model# m-4900-08 serial# (b)(4)).Pentaray nav eco catheter (model# d-1282-08-s lot# 17660352l).(b)(4) are related to the same incident.

Event Description

It was reported that a female patient underwent an ablation procedure for atrial fibrillation with a thermocool® smarttouch® uni-directional navigation catheter and a soundstar® 3d diagnostic ultrasound catheter and suffered a cardiac tamponade (requiring pericardiocentesis and surgical intervention), cardiac arrest (requiring cardiopulmonary resuscitation), and death.During the procedure, a tamponade was confirmed via ultrasound.Initial pericardiocentesis yielded 660ml of fluid.Patient was reported to be in stable condition and was scheduled to be transferred to the coronary care unit for observation.A later report indicated that 2500ml was drained.Thoracotomy revealed a perforation in the right ventricular outflow tract (rvot) and right ventricular trauma secondary to chest compressions.Intracardiac echocardiogram (ice) catheter was in the patient¿s heart while monitoring the tamponade and remained there during chest compressions.It was noted that the ice (soundstar) catheter may have contributed to the injuries.Medical history included steroid medication that impaired the integrity of the cardiac tissue, which made it impossible for the surgeon to repair the perforation.Patient expired during the surgical intervention.Patient did not require extended hospitalization as a result of the adverse event.Physician did not provide a causality opinion regarding the adverse event or the death event.

• Brand Name: SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER
• Type of Device: SIMILAR DEVICE SNDSTR10, 510K # K070242
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6589706
• MDR Text Key: 75972928
• Report Number: 2029046-2017-00181
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-5723-00
• Device Catalogue Number: M572300
• Device Lot Number: OEM_M-5723-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2017
• 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
• Patient Outcome(s): Death; Required Intervention