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

Model Number	U4150410RX
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, a lot history review will be performed.The device was returned to bd and are pending evaluation.A photo and a device were provided for review.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 indicated that the model u4150410rx pta balloon dilatation catheter allegedly ruptured under rated burst pressure.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient was a male; however, the age and weight were unknown.
Additional Manufacturer Narrative
H10: the lot number for the device was provided, a lot history review was performed.The device was returned for evaluation and photos are provided and reviewed.Therefore, the investigation is confirmed for the reported balloon rupture, as longitudinal rupture was noted on the balloon.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 indicated that the model u4150410rx pta balloon dilatation catheter allegedly ruptured under rated burst pressure.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient was a male; however, the age and weight were unknown.

• 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: 10308364
• Report Number: 2020394-2020-04893
• Device Sequence Number: 14295598
• Product Code: LIT
• UDI-Device Identifier: 00801741057557
• UDI-Public: (01)00801741057557
• 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): 10/15/2020

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: U4150410RX
• Device Catalogue Number: U4150410RX
• Device Lot Number: CMDX0413
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 10/15/2020
• Patient Sequence Number: 1