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

Model Number	U415034RX
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for both reported malfunctions; therefore, a lot history review is currently being performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigations of the reported events are inconclusive.Based upon the available information, the definitive root cause for these events are unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model u415034rx ultraverse rx pta dilatation catheter allegedly experienced balloon material rupture.This information was received from multiple sources.Out of the two reported malfunctions, both patients were involved with no patient consequence or impact.One patient was a male, no age and weight information was provided.
Additional Manufacturer Narrative
H10: the two malfunctions were reassessed and determined to be not reportable.The lot number was provided for both reported malfunctions; therefore, a lot history review is currently being performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigations of the reported events are inconclusive.Based upon the available information, the definitive root cause for these events are unknown.The devices are 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 two malfunctions.A review of the reported information indicated that model u415034rx ultraverse rx pta dilatation catheter allegedly experienced balloon material rupture.This information was received from multiple sources.Out of the two reported malfunctions, both patients were involved with no patient consequence or impact.One patient was a male, no age and weight information was provided.

• Brand Name: ULTRAVERSE RX 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: 9594167
• Report Number: 2020394-2020-00421
• Device Sequence Number: 534909
• Product Code: LIT
• UDI-Device Identifier: 00801741056802
• UDI-Public: (01)00801741056802
• 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: U415034RX
• Device Catalogue Number: U415034RX
• Device Lot Number: CMCR0187, CMCT0406
• 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