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

Model Number	U415074RX
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 the three reported malfunctions was provided, therefore lot history reviews were performed.The devices were not returned to the manufacturer for evaluation/inspection.Therefore, the investigation of all the three malfunctions are inconclusive for the reported balloon rupture as no objective evidence was provided.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model u415074rx pta balloon dilatation catheter allegedly experienced balloon rupture.These reports were received from various sources.Three malfunctions were involved with no patient consequences.One patient is an 80 year old female, whose weight was not provided.Age, gender and weight were not provided for the remaining two patients.

• 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: 10309414
• Report Number: 2020394-2020-04925
• Device Sequence Number: 859961
• Product Code: LIT
• UDI-Device Identifier: 00801741058103
• UDI-Public: (01)00801741058103
• 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: U415074RX
• Device Catalogue Number: U415074RX
• Device Lot Number: CMEQ0120,CMDW0138,CMBW0556
• 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