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

Model Number	U4150222
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the one reported event, the one device was returned to bd and evaluated.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model u4150222 pta balloon dilatation catheter allegedly detached.These report was received from one source.Of the one event, did not involved patient with no reported patient contact.The patients' age ranged from (b)(6) years, weight was (b)(6) kgs.Of the reported patients, one was female.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model u4150222 pta balloon dilatation catheter allegedly detached.These report was received from one source.Of the one event, did not involved patient with no reported patient contact.The patients' age ranged from 64 years, weight was 63 kgs.Of the reported patients, one was female.
Additional Manufacturer Narrative
For the one reported event, lot number was provided and lot history review was performed.The device was returned.A visual inspection found the device was received in two separate segments.A completed detachment of the balloon from the catheter was noted, and a complete circumferential break of the guidewire lumen was noted.Therefore, the investigation is confirmed the reported detachment.The definitive root cause for the identified detachment could not be determined based on the available information.It is unknown if procedural issues contributed to the reported event.

• 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: 8519698
• Report Number: 2020394-2019-00345
• Device Sequence Number: 1920055
• Product Code: LIT
• UDI-Device Identifier: 00801741053474
• UDI-Public: (01)00801741053474
• 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): 07/23/2019

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: U4150222
• Device Catalogue Number: U4150222
• Device Lot Number: CMCY0110
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1