MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Ultraverse 018; PTA Balloon Dilatation Catheter

Catalog Number	U8150530
Medical Device Problem Codes	Inflation Problem (1310); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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) 2026, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the ultraverse 018 balloon catheter.During the procedure, it was noticed that the balloon catheter allegedly unable to inflate.The procedure was completed using another balloon.There was no reported patient injury.
Event or Problem Description
On (b)(6)2026, a 48-year-old male patient underwent a percutaneous transluminal angioplasty (pta) procedure using the ultraverse 018 balloon catheter.During the procedure, the balloon catheter allegedly unable to inflate and the particles came from inside of the balloon.The procedure was completed using another balloon.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: received one ultraverse 018 pta dilatation catheter.Upon visual inspection.No anomalies to the ybody or luers.No unknown particles were noted to the catheter shaft or balloon.On functional testing, prior to testing negative pressure was applied to the balloon with an in-house presto inflation device.With the same in-house presto inflation device, the balloon was inflated.Balloon maintained pressure and no water was noted to be streaming from the balloon.The sample guide-wire lumen was flushed successfully and no unknow particles were noted exiting from the guidewire lumen.No other functional testing performed.Therefore, the investigation for the reported inflation issue is unconfirmed as the balloon was inflated and maintained pressure and also the investigation is unconfirmed for the reported device contamination as no unknow particles were noted exiting from the guidewire lumen.A definitive root cause for the reported inflation 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, d4 (unique identifier (udi) #), e1, g3, h6 (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.

• Brand Name: Ultraverse 018
• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 24856074
• Report Number: 2020394-2026-00919
• Device Sequence Number: 10476348
• Product Code: LIT
• UDI-Device Identifier: 00801741065194
• UDI-Public: (01)00801741065194(11)250825(17)280731(10)CMKV0226
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K121856
• 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,Followup
• Report Date (Section B): 08/06/2026

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: U8150530
• Device Lot Number: CMKV0226
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 179 LB
• Patient Race: White