MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U81502H30
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot numbers were provided for all malfunctions and a lot history review will be performed.The three samples were returned for evaluation.Detachment was identified in one of the evaluations.The remaining investigations are pending.The devices were labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model, u81502h30, pta dilatation balloon catheter, allegedly experienced detachment of device or component, and a packaging issue.This information was received from multiple sources.The malfunctions did not involve patients.
Additional Manufacturer Narrative
H10: the lot numbers were provided for all malfunctions and a lot history review will be performed.The three samples were returned for evaluation.Three malfunctions were confirmed for detachment of the device and a packaging problem.One malfunction was also confirmed for 1069 - break.Based upon the available information, a definitive root cause is unknown.The devices were 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 three malfunctions.A review of the reported information indicated that model, u81502h30, pta dilatation balloon catheter, allegedly experienced detachment of device or component, and a packaging issue.This information was recieved from multiple sources.The malfunctions did not involve patients.

• Brand Name: ULTRAVERSE 018 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: 9592075
• Report Number: 2020394-2020-00312
• Device Sequence Number: 16936632
• Product Code: LIT
• UDI-Device Identifier: 00801741064838
• UDI-Public: (01)00801741064838
• 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: U81502H30
• Device Catalogue Number: U81502H30
• Device Lot Number: CMDU0626
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1