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

Model Number	U357584
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation.The company is still investigating the issue at this time.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 u357584 pta balloon dilatation catheter allegedly experienced material rupture, retraction problem, and detachment.This information was received from one source.This malfunction involved a patient with no consequences.The (b)(6) female patient weighed (b)(6).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u357584 pta balloon dilatation catheter allegedly experienced material rupture, retraction problem, and detachment.This information was received from one source.This malfunction involved a patient with no consequences.The 72 year old female patient weighed 105 pounds.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation.The investigation is confirmed for the catheter detachment; however, the investigation is inconclusive for the reported balloon rupture and retraction problem.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4 h11: g1, h6 (method, result, 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.

• 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: 9975067
• Report Number: 2020394-2020-03000
• Device Sequence Number: 19026805
• Product Code: LIT
• UDI-Device Identifier: 00801741093951
• UDI-Public: (01)00801741093951
• 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): 07/07/2020

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: U357584
• Device Catalogue Number: U357584
• Device Lot Number: CMDU0023
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 07/07/2020
• Patient Sequence Number: 1