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

Model Number	U4150215RX
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the two reported malfunctions was provided; therefore, a lot history review is currently being performed.Of the two malfunctions, one device was returned for evaluation.Material rupture was identified in the one returned device.The remaining investigation is inconclusive due to no sample return.The definitive root cause for the reported event is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model u4150215rx pta balloon dilatation catheter allegedly experienced material rupture.This information was received from various sources.Of the two material ruptures, both involved patients with no patient consequences.The two patients ranged from 68-87 years of age and 54-65 kgs.Of the two reported patients, both were male.

• 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: 9964565
• Report Number: 2020394-2020-02738
• Device Sequence Number: 2547267
• Product Code: LIT
• UDI-Device Identifier: 00801741056291
• UDI-Public: (01)00801741056291
• 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
• Report Date (Section B): 04/15/2020

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: U4150215RX
• Device Catalogue Number: U4150215RX
• Device Lot Number: CMDS0499
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1