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

Model Number	U41501Q1HRX
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model u41501q1hrx ultraverse rx pta dilatation catheter ruptured.Of this event, the device was used on the patient but the patient was not injured.The female patient¿s age and weight were not provided.The u41501q1hrx ultraverse rx pta dilatation catheter was not returned.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model u41501q1hrx ultraverse rx pta dilatation catheter ruptured.Of this event, the device was used on the patient but the patient was not injured.The female patient¿s age and weight were not provided.The u41501q1hrx ultraverse rx pta dilatation catheter was not returned.
Additional Manufacturer Narrative
H10: the reported malfunction was reassessed for reportability and determined to be no longer reportable.H10: g4 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.

• 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: 8525304
• Report Number: 2020394-2019-00472
• Device Sequence Number: 1884265
• Product Code: LIT
• UDI-Device Identifier: 00801741055546
• UDI-Public: (01)00801741055546
• 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: U41501Q1HRX
• Device Catalogue Number: U41501Q1HRX
• Device Lot Number: CMCT0538
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1