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

Model Number	U415064RX
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 device was provided, a lot history review is currently being performed.The sample returned to the manufacturer for inspection/evaluation and photo also received for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model u415064rx pta balloon dilatation catheter allegedly experienced material rupture.The information was received from a single source.One patient was involved with no reported patient injury.Age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned for evaluation as well as two photos were provided and reviewed.The investigation for the reported balloon rupture was unconfirmed.The definitive root cause for the reported balloon rupture could not be determined based upon available information.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model u415064rx pta balloon dilatation catheter allegedly experienced material rupture.The information was received from a single source.One patient was involved with no reported patient injury.Age, weight and gender were 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: 10308243
• Report Number: 2020394-2020-04891
• Device Sequence Number: 3371306
• Product Code: LIT
• UDI-Device Identifier: 00801741058066
• UDI-Public: (01)00801741058066
• 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,Followup
• Report Date (Section B): 01/08/2021

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: U415064RX
• Device Catalogue Number: U415064RX
• Device Lot Number: CMEN0578
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1