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

Model Number	U41502H30RX
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
As the lot number for the devices were provided, a device history review was performed.Two out of the three samples were not returned for evaluation and hence the alleged malfunction remains inconclusive for them.Investigation of the returned device confirmed that the device could not inflate.Based upon the available information, the definitive root cause of the reported events is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model u41502h30rx pta dilatation catheter allegedly experienced balloon rupture.This information was received from various sources.Of the three malfunction, three patients were involved with no patient consequences or impact.The patients involved were one (b)(6) years old female, one male of unknown age and the gender of the other patient was not reported.The weight of none of the patients were reported.

• 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: 10311163
• Report Number: 2020394-2020-04956
• Device Sequence Number: 824905
• Product Code: LIT
• UDI-Device Identifier: 00801741056710
• UDI-Public: (01)00801741056710
• 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: U41502H30RX
• Device Catalogue Number: U41502H30RX
• Device Lot Number: CMCQ0074; CMBZ0011; CMDX0232
• 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