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

Model Number	U4150210RX
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 was provided for three out of three malfunctions; therefore, a lot history review is currently being performed.The sample was discarded for one malfunction and two samples were not retuned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive for the three reported malfunctions.Based upon the available information, the definitive root cause for this event 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 u4150210rx pta balloon dilatation catheter allegedly experienced *alleged balloon rupture.This information was received from various sources.These malfunctions involved patients with no consequences.Age, weight, and gender of the patient were not provided.
Additional Manufacturer Narrative
H10: the lot number for the three reported malfunctions were provided, therefore lot history reviews were performed.The samples were discarded for all malfunctions and were not retuned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive for the three reported malfunctions.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model u4150210rx pta balloon dilatation catheter allegedly experienced balloon rupture.This information was received from various sources.These malfunctions involved patients with no consequences.Age, weight, and gender of the patient were 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: 10310746
• Report Number: 2020394-2020-04952
• Device Sequence Number: 824900
• Product Code: LIT
• UDI-Device Identifier: 00801741056239
• UDI-Public: (01)00801741056239
• 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): 10/21/2020

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: U4150210RX
• Device Catalogue Number: U4150210RX
• Device Lot Number: CMDQ0309, CMEN0171
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1