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

Model Number	U8130522
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 the reported malfunction; therefore, a lot history review was performed.The sample was not returned for evaluation.The investigation was inconclusive for the reported balloon rupture issue.A definitive root cause for the reported balloon rupture issue could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model u8130522 pta balloon dilatation catheter allegedly experienced balloon rupture.The information was received from one source.One patient was involved with no reported patient injury.The male patient is (b)(6) and (b)(6).

• 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: 10309191
• Report Number: 2020394-2020-04911
• Device Sequence Number: 859955
• Product Code: LIT
• UDI-Device Identifier: 00801741055249
• UDI-Public: (01)00801741055249
• 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: U8130522
• Device Catalogue Number: U8130522
• Device Lot Number: CMBW0476
• 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