MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U8130415
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u8130415 pta balloon dilatation catheter allegedly experienced material puncture.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a (b)(6)-year-old male whose weight was not provided.
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The investigation is unconfirmed for the reported guidewire issue.A root cause has not been determined.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u8130415 pta balloon dilatation catheter allegedly experienced material puncture.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 65-year-old male whose weight was not provided.

• Brand Name: ULTRAVERSE 018 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: 8814310
• Report Number: 2020394-2019-01724
• Device Sequence Number: 2563472
• Product Code: LIT
• UDI-Device Identifier: 00801741055065
• UDI-Public: (01)00801741055065
• 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): 10/17/2019

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: U8130415
• Device Catalogue Number: U8130415
• Device Lot Number: CMCT0503
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1