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 four out of four malfunctions; therefore, lot history reviews are currently being performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigations of the reported events are inconclusive for the reported material rupture.Based upon the available information, the definitive root cause for this event is unknown.The device(s) are labeled for single use.
Event or Problem Description
This report summarizes four malfunctions.A review of the reported information indicated that model u415034rx pta balloon dilatation catheter allegedly experienced balloon rupture.This information was received from various sources.These malfunctions involved patients with no consequences.Two patients ranged from 76-83 years of age and 63-70 kgs.Of the reported patients, two was male and one were female.All remaining patient information was not 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: 10311009
• Report Number: 2020394-2020-04957
• Device Sequence Number: 824902
• 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
• Report Date (Section B): 07/22/2020

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: CMDX0446, CMDX0450, CMDU0249
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1