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

Model Number	ATG80126
Medical Device Problem Codes	Leak/Splash (1354); Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided and a lot history review was performed.The device was returned and the investigation confirmed for rupture and peeled outer layer, but is unconfirmed for leak.The definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg80126 pta balloon dilatation catheter allegedly experienced leak, peeled layer, and material rupture.This information was received from one source.One patient was involved and there was no reported patient injury.The female patient is 68 years old and weighs 83 kgs.

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9195121
• Report Number: 2020394-2019-03977
• Device Sequence Number: 3763648
• Product Code: LIT
• UDI-Device Identifier: 00801741060717
• UDI-Public: (01)00801741060717
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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
• Operator of Device: No Information
• Device Model Number: ATG80126
• Device Catalogue Number: ATG80126
• Device Lot Number: 93UC0100
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1