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

Model Number	AT75186
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 device history records for both lot numbers have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The devices have been returned for evaluation; the investigation is confirmed for a material rupture.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes two (2) malfunction events.A review of the events indicated that model at75186 dilatation catheter experienced a material rupture.These events were reported from various sources.Both events involved patients with no reported injury.The two (2) patients were both reported as females (b)(6) years of age whose weight ranged from (b)(6) lbs.

• 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: 8520633
• Report Number: 2020394-2019-00362
• Device Sequence Number: 1473754
• Product Code: LIT
• UDI-Device Identifier: 00801741062506
• UDI-Public: (01)00801741062506
• 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): 04/16/2019

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: AT75186
• Device Catalogue Number: AT75186
• Device Lot Number: GFCY2089, GFCY2820
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1