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

Model Number	U357584
Medical Device Problem Codes	Difficult to Insert (1316); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported complaint, the devices were returned to bd.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.A review of the reported information indicated that model u357584.Pta balloon dilatation catheter allegedly experienced retraction problem and difficult to insert.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The device was returned and the investigation is confirmed for the retraction issue, but inconclusive for the reported insertion difficulty.A definitive root cause could not be established.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 u357584.Pta balloon dilatation catheter allegedly experienced retraction problem and difficult to insert.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were 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: 9199603
• Report Number: 2020394-2019-04023
• Device Sequence Number: 10839089
• Product Code: LIT
• UDI-Device Identifier: 00801741093951
• UDI-Public: (01)00801741093951
• 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): 01/07/2020

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: U357584
• Device Catalogue Number: U357584
• Device Lot Number: CMCY0147
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1