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

Model Number	AT75124
Medical Device Problem Codes	Material Frayed (1262); Inflation Problem (1310); Peeled/Delaminated (1454)
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 was performed.The sample was returned and the investigation confirmed for frayed fibers, peeling pebax, unraveled fibers, and uneven inflation.The definitive root cause could not be established.The device is labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model at75124 pta balloon dilatation catheter allegedly experienced material frayed, inflation issues, peeled layer, and unraveled material.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.

• Brand Name: ATLAS 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: 9194970
• Report Number: 2020394-2019-03971
• Device Sequence Number: 2550008
• Product Code: LIT
• UDI-Device Identifier: 00801741062407
• UDI-Public: (01)00801741062407
• 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): 10/15/2019

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: AT75124
• Device Catalogue Number: AT75124
• Device Lot Number: GFDQ0435
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1