MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS 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 device history records have been reviewed with special attention to the (b)(4) 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.A visual inspection found frayed fibers on the balloon.Additionally, when the device was inflated, a pinhole rupture was noted.Therefore, the investigation is confirmed for frayed fibers and for a pinhole 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 failures could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model at75186 pta balloon dilatation catheter during an angioplasty procedure of a calcified lesion in the left common iliac vein, the pta balloon allegedly ruptured at 10atm during the third inflation attempt.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.This report was received from one source.This event involved one female patient, (b)(6) years of age weighing (b)(6) lbs.There was no reported patient injury.

• Brand Name: ATLAS PTA BALLOON 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: 8531949
• Report Number: 2020394-2019-00495
• Device Sequence Number: 1611727
• Product Code: DQY
• 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): 04/19/2019

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: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1