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); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.A visual inspection found frayed and unraveled fibers on the balloon.The device was inflated during functional testing and water was seen exiting from the balloon.The fibers were removed, and a longitudinal rupture was identified.Therefore, the investigation is confirmed for frayed and unraveled material, as well as a longitudinal rupture.Per the reported event details, the target lesion was calcified, and a wall stent was present during the procedure.Therefore, it is possible that patient and/or procedural issues contributed to the event.However, the definitive root cause for the identified compound rupture could not be determined based upon available information.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model at75186 pta balloon dilatation catheter allegedly experienced material frayed, material rupture, and unraveled material.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old female patient was (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: 8808485
• Report Number: 2020394-2019-01625
• Device Sequence Number: 13533204
• 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: GFCY2089
• 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