MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS®; CATHETER, PERCUTANEOUS

Model Number	AT75126
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
While trying to remove an atlas pta balloon dilation catheter, it would not deflate completely.The patient had to be taken to the operating room (or) for surgical removal.Some pain was noted in patient chart, but overall the patient recovered without further intervention and was discharged the next day.Other balloons of this type were removed from the shelves by the nurse manager and the rep was notified to come in.At this time, more information is being collected on specific device details, whether the device was saved, and what communication has occurred between the manufacturer and the interventional radiology department.Per site reporter: the manufacturer rep was notified and instructed to come in by the interventional radiology department.It is unknown at this time whether or not the device was saved and will be passed to the manufacturer rep.

• Brand Name: ATLAS®
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• MDR Report Key: 6975764
• Report Number: 6975764
• Device Sequence Number: 11087475
• Product Code: DQY
• UDI-Device Identifier: 00801741062414
• UDI-Public: (01)00801741062414
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017
• Report Date (Section F): 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Model Number: AT75126
• Device Catalogue Number: AT75126
• Device Lot Number: GFBR2775
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2017
• 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; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 115
• Date Report Sent to FDA: 10/20/2017