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

Catalog Number ATG80144

Device Problem Material Perforation (2205)

Patient Problem No Patient Involvement (2645)

Event Date 05/02/2014

Event Type  malfunction  

Event Description

Balloon perforated prior to rated burst pressure.Manufacturer response for atlas gold balloon, atlas gold (per site reporter)
=
took description of incident, will send a return kit so product can be sent in for a qa.

• Brand Name: ATLAS GOLD
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1415 west third street; suite 109; tempe AZ 85280
• MDR Report Key: 4127962
• MDR Text Key: 4936561
• Report Number: 4127962
• Device Sequence Number: 1
• Product Code: DQY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: ATG80144
• Device Lot Number: 93KX0137
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2014
• Patient Sequence Number: 1