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

Model Number	ATG80166
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546)
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 events indicated that model atg80166 atlas gold pta balloon dilatation catheter allegedly ruptured then frayed.The event did involve the patient but there was no impact or consequence to the patient.The patient was a (b)(6) year-old female weighing (b)(6) lbs.The atg80166 atlas gold pta balloon dilatation catheter was returned to the manufacturer and is undergoing evaluation.The results are not available at this time.
Additional Manufacturer Narrative
H10: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was returned for evaluation.A visual inspection found frayed fibers on the barrel of the balloon.The device was inflated and a rupture was noted on the balloon.Therefore, the investigation is confirmed for frayed fibers and for a rupture.The definitive root cause for the identified issues could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model atg80166 atlas gold pta balloon dilatation catheter allegedly ruptured then frayed.The event did involve the patient but there was no impact or consequence to the patient.The patient was a 54-year-old female weighing 202 lbs.

• 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: 8515195
• Report Number: 2020394-2019-00290
• Device Sequence Number: 2515914
• 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): 07/25/2019

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: ATG80166
• Device Catalogue Number: ATG80166
• Device Lot Number: 93XC0051
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1