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

Model Number	U4200310RX
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); 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
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 u4200310rx pta balloon dilatation catheter allegedly had difficulty inserting through the sheath.These report was received from one source.Of the one event, did involved patient with no reported patient injury.The patients' age ranged from (b)(6) years, weight was (b)(6) lbs.Of the reported patient, one was female.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u4200310rx pta balloon dilatation catheter allegedly experienced a break, difficult to insert, and a detachment of device component.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 74-year-old female weighing 120 lbs.
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the investigation is confirmed for detachment.It is likely the user perceived the detachment as a break.The investigation is inconclusive for the alleged insertion issue as functional testing could not be conducted.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

• 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: 8500160
• Report Number: 2020394-2019-00263
• Device Sequence Number: 11233951
• Product Code: LIT
• UDI-Device Identifier: 00801741056901
• UDI-Public: (01)00801741056901
• 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: U4200310RX
• Device Catalogue Number: U4200310RX
• Device Lot Number: CMCS0322
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1