MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SLEEK RX PTA CATHETER; PTA DILATATION CATHETER

Model Number	425-2015X
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the events indicated that model 425-2015x pta catheter allegedly failed to cross the lesion in the anterior tibial artery.This report was received from one source.This event involved one patient whose age, weight and gender was not provided.This patient had no reported patient injury.

• Brand Name: SLEEK RX PTA CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8533004
• Report Number: 9616666-2019-00047
• Device Sequence Number: 1839404
• Product Code: LIT
• UDI-Device Identifier: 00801741132278
• UDI-Public: (01)00801741132278
• 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: 425-2015X
• Device Catalogue Number: 425-2015X
• Device Lot Number: 50130823
• 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