MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U41502H30
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes 1 malfunction event.A review of the event indicated that model u41502h30 dilatation catheter experienced a detachment of device or component.This event was reported from a single source.This event involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.
Additional Manufacturer Narrative
For the reported malfunction event, the lot number was provided, therefore a lot history review was performed.Of the one device that was returned, a visual inspection found a complete circumferential break to the catheter; however, the inner guidewire lumen was intact.Therefore, the investigation is unconfirmed for detachment confirmed for catheter break.The definitive root cause could not be determined.The device is labeled for single use.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 1 malfunction event.A review of the event indicated that model u41502h30 pta dilatation catheter experienced a detachment of device or component.This event was reported from a single source.This event involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.

• Brand Name: ULTRAVERSE 014 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: 8516815
• Report Number: 2020394-2019-00330
• Device Sequence Number: 1501717
• Product Code: LIT
• UDI-Device Identifier: 00801741064449
• UDI-Public: (01)00801741064449
• 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): 07/25/2019

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: U41502H30
• Device Catalogue Number: U41502H30
• Device Lot Number: CMCP0255
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1