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

Catalog Number	U415044RX
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent for a percutaneous transluminal angioplasty procedure using an ultraverse rx.During the procedure, the balloon, after passing a wire through the iliac lesion.The guiding sheath was significantly bent at the arch of the aorta, causing the shaft section to kink during product delivery.Delivery to the lesion was somehow achieved, but pushability was ineffective and the product could not be passed through the lesion.Successful dilation.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be 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 instructions for use (ifu) are adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Section a through f: the information provide by bd represents all 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported failure to advance could and material deformation could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier udi) #), g2, g3, h6 (method) section a through f: the information provide by bd represents all 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
On (b)(6) 2025, a patient underwent for a percutaneous transluminal angioplasty procedure using an ultraverse rx.During the procedure, the balloon, after passing a wire through the iliac lesion.The guiding sheath was significantly bent at the arch of the aorta, causing the shaft section to kink during product delivery.Delivery to the lesion was somehow achieved, but pushability was ineffective and the product could not be passed through the lesion.Successful dilation.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22504538
• Report Number: 2020394-2025-01026
• Device Sequence Number: 9246972
• Product Code: LIT
• UDI-Device Identifier: 00801741057465
• UDI-Public: (01)00801741057465(11)241113(17)271031(10)CMJY0184
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: Health Professional
• Device Catalogue Number: U415044RX
• Device Lot Number: CMJY0184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown