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

Model Number	ATG120162
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and a lot history review was performed.The device was returned for evaluation.The investigation identified a break and device damaged prior to use.A root cause could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model atg120162 pta dilatation catheter allegedly experienced device damaged prior to use and break.The information was received from one source.The malfunction did not involve a patient.Patient information was not provided.

• Brand Name: ATLAS GOLD PTA BALLOON 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: 9968566
• Report Number: 2020394-2020-02873
• Device Sequence Number: 19953934
• Product Code: DQY
• UDI-Device Identifier: 00801741060809
• UDI-Public: (01)00801741060809
• 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): 04/16/2020

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: ATG120162
• Device Catalogue Number: ATG120162
• Device Lot Number: 93SD0133
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/16/2020
• Patient Sequence Number: 1