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	No Display/Image (1183)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
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 prior to a ventricular tachycardia (vt) procedure, the catheter was connected to the ultrasound system and inserted into the patient's anatomy.In the middle of the procedure, it was observed that there was no image being displayed on the ultrasound system.The catheter was removed and a replacement catheter was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Investigation: the complaint was investigated for no image being displayed on the catheter.Tthis event was initially reported on ventricular tachycardia (vt) procedure, but based on the additional information received, it occurred on an atrial tachycardia (at) procedure.Also, the use of another catheter to complete the study led to a delay of 30 mins.There was no harm to the patient due to this event.The returned catheter was inspected.During the investigation it was found that the cause of this issue was acoustic array de-lamination due to user mishandling.In this case, the user is advised to use extra caution when handling the imaging area of the catheter.Complaint reference #: (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: 6894524
• Report Number: 3009498591-2017-00402
• Device Sequence Number: 10921813
• Product Code: OBJ
• UDI-Device Identifier: 04056869001029
• UDI-Public: 04056869001029
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K071234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2018
• Device Model Number: ACUNAV 8F-90
• Device Catalogue Number: 10135936
• Device Lot Number: QE176402
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1