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

Model Number	ATG120204
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for the malfunction and lot history review will be performed.One device and electronic photo were returned for review.The investigation identified balloon detachment.A definite root cause could not be determined.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model atg120204 pta balloon dilatation catheter allegedly experienced detachment of device or device component.This information was received from one source.The malfunction involve a patient with no reported consequences.The (b)(6) year old male patient's weight was not provided.

• 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: 9593193
• Report Number: 2020394-2020-00338
• Device Sequence Number: 3461316
• Product Code: LIT
• UDI-Device Identifier: 00801741060946
• UDI-Public: (01)00801741060946
• 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): 01/15/2020

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: ATG120204
• Device Catalogue Number: ATG120204
• Device Lot Number: 93UC0101
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1