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

Model Number	ATG80166
Medical Device Problem Codes	Material Frayed (1262); 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
(b)(4).The device for this event has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 atg80166 dilatation catheter experienced material frayed, a retraction problem, a detachment of device or component, and a material rupture.This event was reported from a single source.The event involved a patient with no reported injury.The patient was a (b)(6) year old female weighing (b)(6) lbs.
Additional Manufacturer Narrative
H10: of the 1 device, lot number was provided, and lot history review was performed.Of the reported malfunction, the device was returned for evaluation.Under magnification balloon fibers stripped and material frayed were identified for 1 device.A root cause has not been determined.The device was labeled for single use.H10: g4.H11: b5, h6 device code + descriptio (2907 - detachment of device or device component), h6 (results, conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model atg80166pta balloon dilatation catheter experienced material frayed, a retraction problem, a detachment of device or component, and a material rupture.This event was reported from a single source.The event involved a patient with no reported injury.The patient was a 58 year old, female and weighing 110 lbs.

• Brand Name: ATLAS GOLD 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: 8515090
• Report Number: 2020394-2019-00287
• Device Sequence Number: 16634869
• Product Code: LIT
• UDI-Device Identifier: 00801741060830
• UDI-Public: (01)00801741060830
• 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: ATG80166
• Device Catalogue Number: ATG80166
• Device Lot Number: 93XC0051
• 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