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

Catalog Number	U41501H12RX
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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: one ultraverse rx dilatation catheter returned for evaluation.Upon visual inspection, multiple bends were noted on the catheter.One bend was noted near the rx gw port.Slight bunching was noted on the proximal end of the balloon.No anomalies noted to the inflation hub.During functional testing, the device guidewire lumen was flushed and water exited form the rx gw exit port.An in-house gw 014 was inserted from the distal tip and was able to be inserted without no issue but could not exit from the rx port due to the tear.An in-house sheath was flushed and without negative pressure was inserted through the sheath without issue.Balloon was not able to be inflated due to the tear.The balloon catheter was retracted without no issue through the sheath.No other functional testing performed.Therefore, the investigation is inconclusive for the reported guidewire removal issues as guidewire testing could not be completely carried out due to inadvertent damage caused by the use of incorrect guidewire.However, the investigation is confirmed for the identified material deformation as multiple bends and slight bunching was noted on the device.The investigation is inconclusive for the reported inability to cross the lesion as the conditions of use could not be replicated in the laboratory.A definitive root cause for the reported failure to advance, guidewire removal issues and identified material 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure through the ultraverse rx balloon catheter.During the procedure, it was reported that the balloon catheter was allegedly unable to cross through the lesion and had difficulty removing the wire.The procedure was completed using another balloon.There were no reported patient injuries.

• Brand Name: ULTRAVERSE RX
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 24033678
• Report Number: 2020394-2026-00003
• Device Sequence Number: 10388379
• Product Code: LIT
• UDI-Device Identifier: 00801741055997
• UDI-Public: (01)00801741055997(11)230831(17)260731(10)CMHV0397
• 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): 01/12/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: U41501H12RX
• Device Lot Number: CMHV0397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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