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

Model Number ATG80166

Device Problems Material Frayed (1262); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event 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.

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 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
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8515195
• MDR Text Key: 142234759
• Report Number: 2020394-2019-00290
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060830
• UDI-Public: (01)00801741060830
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ATG80166
• Device Catalogue Number: ATG80166
• Device Lot Number: 93XC0051
• Date Manufacturer Received: 06/30/2019
• Patient Sequence Number: 1