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

Model Number AT75126

Device Problem Deflation Problem (1149)

Patient Problem Pain (1994)

Event Date 10/11/2017

Event Type  Injury  

Event 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®
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• MDR Report Key: 6975764
• MDR Text Key: 90172358
• Report Number: 6975764
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062414
• UDI-Public: (01)00801741062414
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: AT75126
• Device Catalogue Number: AT75126
• Device Lot Number: GFBR2775
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 115