MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE

Model Number ACUNAV

Device Problem Insufficient Information (3190)

Patient Problems Perforation (2001); Blood Loss (2597)

Event Date 09/19/2013

Event Type  malfunction  

Manufacturer Narrative

This mdr is the result of a retrospective review of complaints for the purpose of identifying concomitant devices.The reported event describes side effects from the procedure or patient symptoms due to their condition.This product is considered a concomitant device and did not contribute to the reported event.

Event Description

It was reported that during a paroxysmal afib case, a perforation of the left atrium was noticed when the catheter was projected outside of the shell.The perforation was confirmed by ice.A pericardiocentesis was performed and 500 ml of fluid were removed.In addition, caller reported that the patient was sent to the or so that a pericardial window could be performed.The status of the patient was unknown.The following bwi devices were in use: carto 3 rmt ((b)(4)), stockert ((b)(4)), cool flow pump ((b)(4)), thermocool f curve catheter (catalog and lot number unknown - disposed of), lasso nav catheter (catalog and lot number unknown - disposed of), and an 8 f accunav catheter (catalog and lot number unknown - disposed of).Reported by (b)(6) medcl ctr.

• Brand Name: ACUSON
• Type of Device: DIAGNOSTIC ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain vew CA 94043 4050
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain vew CA 94043 4050
• Manufacturer Contact: karen smith ; 685 east middlefield road; mountain view, CA 94043-4050
• MDR Report Key: 5796402
• MDR Text Key: 50520995
• Report Number: 3009498591-2016-00205
• Device Sequence Number: 1
• Product Code: ITX
• 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,user f
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUNAV
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1