MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U35130520
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 for the device was provided and a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation was confirmed for the reported balloon rupture.Based upon the available information, the definitive root cause for this malfunction was unknown.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 u35130520 pta balloon dilatation catheter allegedly ruptured.This information was received from one source.The malfunction involved patient with no known impact to the patient.The (b)(6) years old male patient weighed (b)(6) kg.

• Brand Name: ULTRAVERSE 035 PTA 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: 10748829
• Report Number: 2020394-2020-06174
• Device Sequence Number: 17008628
• Product Code: LIT
• UDI-Device Identifier: 00801741092732
• UDI-Public: (01)00801741092732
• 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): 10/28/2020

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: U35130520
• Device Catalogue Number: U35130520
• Device Lot Number: CMDV0056
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1