MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U35130515
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device and packaging were returned for evaluation, for the one reported event.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 u5130515 pta balloon dilatation catheter allegedly had a packaging issue.This report was received from one source.There was no reported patient contact with the device and patient information was not provided.
Additional Manufacturer Narrative
H10: the lot number of the returned device was provided and lot history review performed.It was observed that upon receipt of the device that the outer carton open and inner package seal is not intact.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: b5, g4 h11: h6 (results 1, conclusion 1) 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 u5130515 pta balloon dilatation catheter allegedly had a packaging issue.This report was received from one source.There was no reported patient contact with the device and patient information was not provided.

• Brand Name: ULTRAVERSE 035 PTA 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: 8516616
• Report Number: 2020394-2019-00329
• Device Sequence Number: 2798696
• Product Code: LIT
• UDI-Device Identifier: 00801741092725
• UDI-Public: (01)00801741092725
• 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: U35130515
• Device Catalogue Number: U35130515
• Device Lot Number: CMBY0564
• 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