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

Model Number	ATG80166
Medical Device Problem Code	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 was provided and a lot history review will be performed.The device was returned for evaluation and the investigation is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model atg80166 pta balloon dilatation catheter allegedly experienced material rupture.The information was received from one source.The malfunction involved an (b)(6) female patient weighing (b)(6) with not reported consequences.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The device was returned for evaluation.The investigation is confirmed for balloon rupture and frayed balloon material.The definitive root cause could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model atg80166 pta balloon dilatation catheter allegedly experienced material rupture.The information was received from one source.The malfunction involved an 80 year old female patient weighing 118lbs with not reported consequences.

• 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: 9967985
• Report Number: 2020394-2020-02838
• Device Sequence Number: 11721443
• Product Code: DQY
• UDI-Device Identifier: 00801741060830
• UDI-Public: (01)00801741060830
• 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,Followup
• Report Date (Section B): 06/25/2020

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: ATG80166
• Device Catalogue Number: ATG80166
• Device Lot Number: 93XD0037
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 06/26/2020
• Patient Sequence Number: 1