MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. ATLAS GOLD BALLOON; ATLAS GOLD PTA DILATATION CATHETER

Catalog Number VENDOR ATG8D186

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/17/2018

Event Type  Injury  

Event Description

Balloon became detached from wire and had to be removed surgically.Balloon detached from the shaft while it was inside the patient's vein.

• Brand Name: ATLAS GOLD BALLOON
• Type of Device: ATLAS GOLD PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC.
• MDR Report Key: 7645526
• MDR Text Key: 112774863
• Report Number: MW5078112
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VENDOR ATG8D186
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization