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

Model Number	AT75166
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for this one reported complaint.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model at75166 allegedly ruptured and had retraction issues.This report was received from one source.The device was used inside the patient with no reported injury.The patient involved was as (b)(6) year-old female, of (b)(6) lbs.
Additional Manufacturer Narrative
H10: the device history records 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 device was returned for evaluation.The device was inflated during functional testing and water was seen exiting from the balloon.The fibers were removed, and a partial circumferential rupture was identified.Therefore, the investigation is confirmed for a circumferential rupture.However, the investigation is inconclusive for the reported retraction issue as further functional testing was not viable, due to the rupture.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model at75166 allegedly ruptured and had retraction issues.This report was received from one source.The device was used inside the patient with no reported injury.The patient involved was as sixty year-old female, of 115 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: 8516069
• Report Number: 2020394-2019-00316
• Device Sequence Number: 11157069
• Product Code: LIT
• UDI-Device Identifier: 00801741062476
• UDI-Public: (01)00801741062476
• 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,Followup
• Report Date (Section B): 07/23/2019

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: AT75166
• Device Catalogue Number: AT75166
• Device Lot Number: GFCU3702
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1