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

Catalog Number	U415074RX
Medical Device Problem Codes	Failure to Advance (2524); Device-Device Incompatibility (2919); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
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.Two photos were provided and reviewed.First photo shows a single thin black thread like fragment placed on a white gauze surface and second photo show the packaging and labeling details.The labeling details match with the information available in track wise.Therefore, the investigation is inconclusive for the reported guidewire advancement issue as no objective evidence was provided for the review.The investigation is inconclusive for the reported device contamination as the thin, thread like fragment was not returned for analysis.Although it may resemble an inner guidewire lumen liner, the exact material or source could not be determined.A definitive root cause for the reported guidewire advancement issue and device contamination could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, h6 (method, result, conclusion).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
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the ultraverse rx balloon catheter.It was reported that during the procedure, when attempting to deliver the product via ipsilateral retrograde approach over a 6fr sheath in an iliac case, resistance was encountered starting with initial stiffness, necessitating withdrawal.During withdrawal, a broken guidewire was confirmed, prompting an exchange with a new wire.Further after inserting, the wire into the wire lumen and attempting delivery, resistance was felt midway, preventing successful delivery.Reportedly, upon re-extraction and removal of the wire, a black cord like object emerged.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 was performed.The return of sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the ultraverse rx balloon catheter via ipsilateral retrograde approach.During the procedure, the balloon catheter allegedly unable to advance and foreign object were observed.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: 24017219
• Report Number: 2020394-2026-00001
• Device Sequence Number: 21130147
• Product Code: LIT
• UDI-Device Identifier: 00801741058103
• UDI-Public: (01)00801741058103(11)240715(17)270630(10)CMJU0177
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: U415074RX
• Device Lot Number: CMJU0177
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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