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

Model Number	U357554
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
For the reported malfunctions, the devices were returned to bd for evaluation.The company is still investigating the issue at this time.The devices are labeled for single use.
Event or Problem Description
This report summarizes two (2) malfunctions.A review of the reported information indicated that model u357554 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.Each malfunction involved a patient with no known impact to the patient.The patients' age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: of the two reported malfunctions, one was reassessed for reportability and determined to be no longer reportable.The lot number for the malfunction was provided and a lot history review was performed.The device was returned for the remaining malfunction, the investigation is confirmed for material rupture.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: h6(results, conclusion).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 two (2) malfunctions.A review of the reported information indicated that model u357554 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.Each malfunction involved a patient with no known impact to the patient.The patients' 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: 8812542
• Report Number: 2020394-2019-01669
• Device Sequence Number: 2536725
• Product Code: LIT
• UDI-Device Identifier: 00801741092459
• UDI-Public: (01)00801741092459
• 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): 10/14/2019

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: U357554
• Device Catalogue Number: U357554
• Device Lot Number: CMCY0384, CMDP0175
• 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: 10/14/2019
• Patient Sequence Number: 1