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

Catalog Number	U35130812
Medical Device Problem Codes	Leak/Splash (1354); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Three photos were provided and reviewed.The first photo shows the ultraverse 035 device.No anomalies were noted to the catheter and balloon.The second photo shows the inner packaging of the ultraverse 035 device.The labeling details in the provided photo match with the information available in trackwise.The third photo shows the outer packaging of the ultraverse 035 device.The labeling details in the outer packaging match with the information available in trackwise.One video was provided and reviewed.The video shows the ultraverse 035 device was connected to unknown inflation device.During inflation, liquid leakage was observed from the distal end of the catheter hub.Additionally, the strain relief was found dislodged from the catheter hub.No other anomalies were noted.Therefore, the investigation is confirmed for the reported leak as liquid was noted leaking from the distal end of the catheter hub.Also, the investigation is confirmed for the identified device dislodged as strain relief was dislodged from the catheter hub.A definitive root cause of the reported leak and identified strain relief dislodgement could not be determined based on 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 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) 2026, a patient underwent an angioplasty procedure using the ultraverse 035 pta balloon.During the procedure, it was noticed that fluid leakage was observed at the distal end of the catheter.The procedure was completed using another balloon.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035
• 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: 24880629
• Report Number: 2020394-2026-00923
• Device Sequence Number: 9823905
• Product Code: LIT
• UDI-Device Identifier: 00801741094217
• UDI-Public: (01)00801741094217(17)280831(10)CMKW0316
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: U35130812
• Device Lot Number: CMKW0316
• 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: 03/24/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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