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

Model Number	U41501Q1HRX
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); 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 u41501q1hrx pta balloon dilatation catheter allegedly experienced material separation and detachment of device or device component.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The sex and weight of the (b)(6) year old patient were not provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a lot history review could not be performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation is confirmed for detachment of device and material rupture.A definitive root cause for the reported event could not be determined.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 model u41501q1hrx pta balloon dilatation catheter allegedly experienced material separation and detachment of device or device component.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The sex and weight of the 83 year old patient 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: 10310322
• Report Number: 2020394-2020-04951
• Device Sequence Number: 860555
• Product Code: LIT
• UDI-Device Identifier: 00801741055546
• UDI-Public: (01)00801741055546
• 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: U41501Q1HRX
• Device Catalogue Number: U41501Q1HRX
• Device Lot Number: UNKNOWN
• 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