MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U41502H15
Medical Device Problem Codes	Material Frayed (1262); Peeled/Delaminated (1454); Unraveled Material (1664)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.It was noted that the tip of the balloon was frayed.Based upon the available information, the definitive root cause is unknown.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 u41502h15 pta balloon dilatation catheter allegedly frayed and unraveled.This information was received from a single source.There was no patient contact.The patient age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u41502h15 pta balloon dilatation catheter allegedly peeled and unraveled.This information was received from a single source.There was no patient contact.The patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the device was returned for evaluation.The investigation was confirmed for peeling.The definitive root cause could not be determined.The device is 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.

• Brand Name: ULTRAVERSE 014 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: 8811845
• Report Number: 2020394-2019-01655
• Device Sequence Number: 2587350
• Product Code: LIT
• UDI-Device Identifier: 00801741053627
• UDI-Public: (01)00801741053627
• 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): 10/23/2019

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: U41502H15
• Device Catalogue Number: U41502H15
• Device Lot Number: CMDP0158
• 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: 10/23/2019
• Patient Sequence Number: 1