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

Model Number 10135936

Device Problem Ambient Noise Problem (2877)

Patient Problems Diaphoresis (2452); Pericardial Effusion (3271)

Event Date 04/02/2013

Event Type  Injury  

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." the device referenced in this report was returned for evaluation.During visual inspection, no problem was observed.The device underwent acoustic testing and it passed.

Event Description

It was reported that during an intracardiac echocardiography (ice) procedure, the patient experienced a pericardial effusion.It was noticed that the stocker impedance was 230ohms after 5 seconds of ablating a lateral accessory pathway in the left atrium (la).The catheter was removed from the patient but no coagulation was observed.At this point the patient was diaphoretic and a drop in the patient's blood pressure was noticed.The catheter was inserted back into the la but the impedance was still high.The procedure was aborted and a pericardiocentesis was immediately performed.The patient was reported to be in stable condition.

• Brand Name: ACUSON DIAGNOSTIC ULTRASOUND CATHETER
• Type of Device: DIAGNOSTIC ULTRASOUND CATHETER
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: karen smith ; 685 east middlefield road; mountain view, CA 94043-4050 ; 8004228766
• MDR Report Key: 5807539
• MDR Text Key: 49945040
• Report Number: 3009498591-2016-00222
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10135936
• Device Catalogue Number: 10135936
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2013
• Date Manufacturer Received: 04/02/2013
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other; Required Intervention