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

Model Number	U4150210RX
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 numbers for three malfunctions were provided and lot history reviews were performed.One device has been returned for evaluation; the evaluation confirmed a material rupture.The device has not been returned for two malfunctions; therefore, two investigations are inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model u4150210rx pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.The three malfunctions involved three patients with no patient consequences.The age of two patients were (b)(6).One patient weighed (b)(6) kgs.One patient was reportedly male and one patient was reportedly female.All other 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: 9979837
• Report Number: 2020394-2020-03095
• Device Sequence Number: 2168269
• Product Code: LIT
• UDI-Device Identifier: 00801741056239
• UDI-Public: (01)00801741056239
• 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): 04/20/2020

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: U4150210RX
• Device Catalogue Number: U4150210RX
• Device Lot Number: CMCP0246, CMDT0617
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/20/2020
• Patient Sequence Number: 1