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

Catalog Number	U35130415
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the ultraverse 035 pta balloon catheter to treat for occluded femoropopliteal artery.During the procedure, in the process of pressurization, the pressure was allegedly leaking.It was further reported that the balloon was removed from the patient, and fluid was ejected from the balloon body during re-pressurization.Reportedly, there was a slight resistance while retraction the balloon thru the sheath.The procedure was completed using another device.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: the physical device was not returned for evaluation.Two photos were provided and reviewed.The first photo shows the ultraverse 035 device in transparent packaging.The catalogue number in the photo match with the information available in trackwise.No specific anomalies were noted.The second photo shows the labeling details of the device, that match with the information available in trackwise.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported balloon rupture and difficult to remove 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 (device, component, method, result, conclusion).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 a percutaneous transluminal angioplasty (pta) procedure using the ultraverse 035 pta balloon catheter to treat for occluded femoropopliteal artery.During the procedure, in the process of pressurization, the pressure was allegedly leaking.It was further reported that the balloon was removed from the patient, and fluid was ejected from the balloon body during re-pressurization.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H11: 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.

• Brand Name: ULTRAVERSE 035
• 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: 22059905
• Report Number: 2020394-2025-00781
• Device Sequence Number: 7634803
• Product Code: LIT
• UDI-Device Identifier: 00801741092220
• UDI-Public: (01)00801741092220(11)230112(17)251231(10)CMHN0138
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 12/31/2025
• Device Catalogue Number: U35130415
• Device Lot Number: CMHN0138
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2023
• 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