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

Model Number	AT75186
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
Additional Manufacturer Narrative
The devices were both returned for evaluation.A visual inspection found frayed fibers on the balloons.The devices were inflated during functional testing and water was seen exiting from the balloons.The fibers were removed, and a longitudinal rupture was identified on the first device; pinhole rupture was identified on the second.Therefore, the investigation is confirmed for frayed material, as well as a longitudinal rupture.Per the reported event details, a wall stent was present during the procedures.Therefore, it is possible that patient and/or procedural issues contributed to the alleged malfunctions.However, the definitive root cause for the identified frayed material and longitudinal rupture could not be determined based upon available information.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that material on model at75186 atlas pta dilatation catheters allegedly frayed and ruptured.This information was received from various sources.The alleged malfunctions each involved a patient with no known impact to the patient.Both patients were reported to be female, one patient was reported to be (b)(6)-years-old and weigh (b)(6)lb; the other was reported to be (b)(6) -years-old and weigh (b)(6) lb.

• 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: 8809601
• Report Number: 2020394-2019-01640
• Device Sequence Number: 327097
• 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): 07/19/2019

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: GFCZ1773, GFCY2820
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Patient Sequence Number: 1