MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U35130126
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event 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 u35130126 pta balloon dilatation catheter allegedly broke.This report was received from one source.This malfunction involved one patient with no patient consequences.Age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the complaint was reassessed for reportability and determined to be reportable as a serious injury is reported under emdr number 2020394-2020-05920.H10: the lot number for the malfunction was provided and a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported malfunction was inconclusive.Based upon the available information, the definitive root cause for this event was unknown.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u35130126 pta balloon dilatation catheter allegedly broke.This report was received from one source.This malfunction involved one patient and a surgery was performed to cut-down to access the balloon and remove.Age, weight, and gender were not provided.

• Brand Name: ULTRAVERSE 035 PTA 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: 10305977
• Report Number: 2020394-2020-04803
• Device Sequence Number: 3417031
• Product Code: LIT
• UDI-Device Identifier: 00801741094958
• UDI-Public: (01)00801741094958
• 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): 10/19/2020

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: U35130126
• Device Catalogue Number: U35130126
• Device Lot Number: CMDX0395
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 10/19/2020
• Patient Sequence Number: 1