MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U4150510
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u4150510 pta balloon dilatation catheter allegedly experienced a device markings issue.This information was received from one source.The malfunction did not involve a patient, thus, no patient information was provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation is unconfirmed for the alleged device marking issue.The root cause could not be determined.The device is labeled for single use.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.A review of the reported information indicated that model u4150510 pta balloon dilatation catheter allegedly experienced a device markings issue.This information was received from one source.The malfunction did not involve a patient, thus, no patient information was provided.

• Brand Name: ULTRAVERSE 014 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: 9592300
• Report Number: 2020394-2020-00324
• Device Sequence Number: 2335419
• Product Code: LIT
• UDI-Device Identifier: 00801741054167
• UDI-Public: (01)00801741054167
• 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): 04/02/2020

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: U4150510
• Device Catalogue Number: U4150510
• Device Lot Number: CMDR0083
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1