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

Model Number	U41501H12RX
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 all four of the reported malfunctions was provided and lot history reviews were performed.For all four malfunctions, the devices have not been returned for evaluation; therefore, the investigations are inconclusive for the material rupture as no objective evidence has been provided.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.(corporate lot no: cmdx0027).
Event or Problem Description
This report summarizes four malfunctions.A review of the malfunction indicated that model u41501h12rx pta balloon dilatation catheter allegedly experienced material rupture.These reports were received from various sources.All malfunctions involved a patient with no patient consequences.Of the four patients, one was a (b)(6) year old male and weight was not provided.All other patients information was not provided.

• 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: 10310402
• Report Number: 2020394-2020-04945
• Device Sequence Number: 824899
• Product Code: LIT
• UDI-Device Identifier: 00801741055997
• UDI-Public: (01)00801741055997
• 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): 07/22/2020

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: U41501H12RX
• Device Catalogue Number: U41501H12RX
• Device Lot Number: CMDU0508, CMDR0434, CMDT0407
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1