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

Model Number	U8150215
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); 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 for the device was provided, therefore, a lot history review was performed.The sample was returned for evaluation as well as one electronic video and image.The investigation is confirmed for the reported inflation problem, leak, and rupture.The definitive root cause could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u8150215 pta balloon dilatation catheter allegedly experienced inflation problem, leak, and rupture.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The male patient is (b)(6) years old and his weight was not provided.

• 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: 10760030
• Report Number: 2020394-2020-06342
• Device Sequence Number: 11596561
• Product Code: DQY
• UDI-Device Identifier: 00801741064722
• UDI-Public: (01)00801741064722
• 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): 10/29/2020

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: U8150215
• Device Catalogue Number: U8150215
• Device Lot Number: CMDS0383
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/30/2020
• Patient Sequence Number: 1