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

Catalog Number	U4150230RX
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient was undergoing a percutaneous transluminal angioplasty procedure using an ultraverse rx balloon on target lesion below the knee.During the procedure, it was reported that the balloon allegedly had pinhole rupture at 6 atm due to calcification.It was further reported that 2.5-300 was used and the procedure was completed successfully.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one ultraverse rx dilatation catheter returned for evaluation.Upon visual inspection, there was dried blood within the balloon.The device catheter was returned loaded over an unknown brand guidewire that was extending out of the inflation lumen near the proximal end of the balloon and not from the rapid exchange port as expected.No anomalies noted to the inflation hub.Kinks were noted along the inner gw lumen near the proximal end of the balloon.During functional testing, an in-house presto inflation device was used to inflate the balloon, and water was noted leaking from the inflation lumen near the proximal end of the balloon where the returned gw was extending out from.Under microscopic examination, a longitudinal rupture observed on the inflation lumen.No other functional testing performed.Therefore, the investigation is unconfirmed for the reported balloon rupture as no rupture was noted to the returned balloon.The investigation is confirmed for the identified material split, cut, torn as longitudinal rupture was noted on the inflation lumen.The investigation is confirmed for the identified material deformation as multiple kinks were noted on the inner guidewire lumen at the proximal end of the balloon.A definitive root cause for the reported balloon rupture, identified material split, cut, torn and deformation 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.Section a through f ¿ the information provided 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.

• 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: 23356550
• Report Number: 2020394-2025-01741
• Device Sequence Number: 21048872
• Product Code: LIT
• UDI-Device Identifier: 00801741056383
• UDI-Public: (01)00801741056383(11)231003(17)260930(10)CMHX0039
• 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
• Report Date (Section B): 10/14/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: U4150230RX
• Device Lot Number: CMHX0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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