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

Catalog Number	U357554
Medical Device Problem Codes	Deflation Problem (1149); Leak/Splash (1354); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
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
A patient underwent for an angioplasty procedure using the ultraverse 035 pta balloon.During the angioplasty procedure, the catheter hub joint allegedly leaked.It was further reported that the balloon was unable to fully deflate.The procedure was completed using another balloon.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty procedure using the ultraverse 035 pta balloon, during the procedure the catheter hub joint allegedly leaked and further it was reported that the balloon was unable to fully deflate.The procedure was completed using another balloon.There was no reported patient injury.
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: one ultraverse 035 pta balloon catheter returned for evaluation.Upon visual inspection, it was noted the balloon was partially inflated.No anomalies noted to the y-body.During functional testing, the device guidewire lumen was flushed and bloody water exited from the distal tip of the balloon catheter.The patency of the guidewire lumen was tested using an in-house guidewire, and it was able to be inserted with resistance due to the dried blood within the catheter.An in-house presto inflation device was used to inflate the balloon, and water was noted leaking from the distal end of the strain relief.No other functional testing performed for difficult to remove since the balloon could not be inflated due to loss of pressure from the leak.Therefore, the investigation is confirmed for the reported leak as water was noted leaking from the distal end of the strain relief.However, the investigation is inconclusive for the reported deflation problem and sheath removal difficulties as functional testing was not performed, since the balloon could not be inflated due to loss of pressure from the leak.A definitive root cause of the reported leak, sheath removal issues and deflation problem 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.B5, h6 (device, component, method, result, conclusion).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.

• 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: 23641927
• Report Number: 2020394-2025-01941
• Device Sequence Number: 15917345
• Product Code: LIT
• UDI-Device Identifier: 00801741092459
• UDI-Public: (01)00801741092459(17)280331(10)CMKR0126
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• 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): 12/12/2025

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: U357554
• Device Lot Number: CMKR0126
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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