MAUDE Adverse Event Report: VERATHON MEDICAL BLADDERSCAN BVI 9600 WITH AORTASCAN MODE; AORTIC ULTRASOUND SCANNER

Model Number 0570-0188

Device Problems False Negative Result (1225); Low Readings (2460)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2013

Event Type  malfunction  

Event Description

The customer reported that the aortascan was reading inaccurately, and not identifying abdominal aortic aneurysms (aaa).One pt scanned in (b)(6) 2013 was not found to have an aneurysm, but then a large aaa was later identified on mri.Seven other pts reportedly had known aneurysms that were not identified with the aortascan.There was no adverse event to any pt.

Manufacturer Narrative

Multiple requests were made to have the device returned for eval/repair, but the customer refused.Not applicable, no pt adverse event.Additional device component: 0570-0212/b6002428.A letter dated on 05/29/2014, has been sent to all customers, informing them of enhancements to the warnings in the user's manual which provide additional guidance and awareness on the proper use of the aortascan.The operations and maintenance manual states that the aortascan is not a diagnostic device and is only intended as an initial screening tool.If clinically indicated, appropriate pts should be referred for a diagnostic standard (confirmatory) test, regardless of test results.

• Brand Name: BLADDERSCAN BVI 9600 WITH AORTASCAN MODE
• Type of Device: AORTIC ULTRASOUND SCANNER
• Manufacturer (Section D): VERATHON MEDICAL; bothell WA
• Manufacturer Contact: adam gaines ; 20001 north creek parkway; bothell, WA 98021 ; 4256295606
• MDR Report Key: 3998263
• MDR Text Key: 4710754
• Report Number: 3022472-2014-00023
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/16/2014

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
• Device Operator: Health Professional
• Device Model Number: 0570-0188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1