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

Model Number	U3513044
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u3513044 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.The event involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u3513044 pta balloon dilatation catheter allegedly experienced material rupture and break.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed break and material rupture.After further evaluation of the device, trending device code has been updated to (1546 - material rupture and 1069 - break ).Based upon the available information, a definitive root cause is unknown.The device was labeled for single use.( device code - 1546 - material rupture and 1069 - break).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.

• 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: 9596593
• Report Number: 2020394-2020-00463
• Device Sequence Number: 16769089
• Product Code: LIT
• UDI-Device Identifier: 00801741092176
• UDI-Public: (01)00801741092176
• 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): 04/06/2020

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: U3513044
• Device Catalogue Number: U3513044
• Device Lot Number: CMBV0387
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1