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

Model Number	AT120144
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model at120144 atlas pta balloon dilation catheter had a dislocated marker band.Of this event, the device was used on the patient but the patient was not injured.The patient¿s age, sex, and weight were not provided.The at120144 atlas pta balloon dilation catheter was not returned, but a dhr was performed on the associated lot number.Results were inconclusive.

• Brand Name: ATLAS PTA BALLOON DILATION CATHETER
• Common Device Name: PTA BALLOON DILATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8522902
• Report Number: 2020394-2019-00391
• Device Sequence Number: 1899756
• Product Code: DQY
• UDI-Device Identifier: 00801741062636
• UDI-Public: (01)00801741062636
• 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): 04/17/2019

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: AT120144
• Device Catalogue Number: AT120144
• Device Lot Number: GFCS3445
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/17/2019
• Patient Sequence Number: 1