MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON ACUNAV 8F-90 ULTRASOUND CATHETER; ULTRASOUND DEVICE

Model Number	ACUNAV 8F-90
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to siemens for evaluation.If additional information is received or if the device is returned at a later date, this report will be supplemented.
Event or Problem Description
It was reported that a patient was put under anesthesia and underwent an atrial fibrillation (afib) cryoballoon ablation procedure.The catheter was inserted into the patient and while the doctor was evaluating the heart with an intracardiac catheter (ice), a poor acoustic imaging was generated by the catheter.The doctor removed the catheter and reinserted a new catheter to complete the procedure using the same ultrasound system.The procedure was delayed by five minutes while a replacement catheter was prepared.Later in the procedure, after the transeptal puncture, the patient developed pericardial effusion.In order to immediately stabilize the patient, the doctor performed pericardiocentesis and aspirated 300ccs of fluid.It is unknown whether this was a result of the reported event; however, the initial report stated that the pericardial effusion was unrelated to the catheter.No additional information was provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the date new information was received and the type of report; provide the type of reportable event, provide the type of follow-up, update the event problem.After several attempts were made to obtain the catheter referenced in the initial report, it was not returned to siemens for investigation.According to engineering, based on trend analysis, the probable cause of the reported phenomenon could be stack damage or saline contamination due to user error.(b)(4).

• Brand Name: ACUSON ACUNAV 8F-90 ULTRASOUND CATHETER
• Common Device Name: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• MDR Report Key: 6888402
• Report Number: 3009498591-2017-00388
• Device Sequence Number: 16343901
• Product Code: OBJ
• UDI-Device Identifier: 04056869001029
• UDI-Public: 04056869001029
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K071234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACUNAV 8F-90
• Device Catalogue Number: 10135936
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other