MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018; PTA BALLOON DILATATION CATHETER

Catalog Number	U8150530
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records was performed.The return of the sample is pending.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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the ultraverse 018 pta balloon catheter via common femoral contralateral approach.During the procedure, the marker on the catheter balloon was allegedly off a centimeter or two.It was further reported that the balloon inflated beyond the marker.Balloon was removed, and angiogram was performed to verify no injury to the vessel.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one ultraverse 018 dilatation catheter returned for evaluation.Upon visual inspection, dried saline/contrast was noted within the balloon with some blood residue.Marker bands were noted to be present, two distal marker bands and one proximal marker band.No anomalies were present to the luers/y-body.During functional testing, the balloon was inflated with an in-house presto inflation device to nominal pressure.Under microscopic observation, the distance between the two marker bands was approximately 0.5cm.No other functional testing was performed.Therefore, the investigation is unconfirmed for the reported issue as the distance between two distal marker bands were within the product specifications.A definitive root cause for the reported device dislodged or dislocated 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.G2, g3, h6 (method, result, conclusion).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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the ultraverse 018 pta balloon catheter via common femoral contralateral approach.During the procedure, the marker on the catheter balloon was allegedly off a centimeter or two.It was further reported that the balloon inflated beyond the marker.Balloon was removed, and angiogram was performed to verify no injury to the vessel.

• Brand Name: ULTRAVERSE 018
• 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: 22201310
• Report Number: 2020394-2025-00872
• Device Sequence Number: 7723461
• Product Code: LIT
• UDI-Device Identifier: 00801741065194
• UDI-Public: (01)00801741065194(11)241022(17)270930(10)CMJX0307
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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 Catalogue Number: U8150530
• Device Lot Number: CMJX0307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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