MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014; PTA BALLOON DILATATION CATHETER

Catalog Number	U4150530
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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
On (b)(6) 2025, prior to an angioplasty procedure using the ultraverse 014 pta balloon, the balloon allegedly disintegrated while prepping.It was further reported that fragments were detached and hanging from end of the catheter.The procedure was completed using another balloon.There was no patient contact.
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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported break 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.G3, h6 (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.
Event or Problem Description
On (b)(6) 2025, a patient prepped for an angioplasty procedure using the ultraverse 014 pta balloon.Prior to the procedure, the balloon allegedly disintegrated while prepping.It was further reported that the fragments were detached and hanging from the end of the catheter.The procedure was completed using another balloon.There was no patient contact.
Event or Problem Description
On (b)(6) 2025, a patient prepped for an angioplasty procedure using the ultraverse 014 pta balloon.Prior to the procedure, the balloon allegedly disintegrated while prepping.It was further reported that the fragments were detached and hanging from the end of the catheter.The procedure was completed using another balloon.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one ultraverse 014 was returned for evaluation.A visual inspection was done and an unknown residue was noted to be present on the distal end of the device.No break or detached portions were seen on the device.The device was sent for ftir & sem/eds testing to determine the material seen on the device.The residue across the balloon was tested, and the material was suggested to be the applied balloon coating delaminating off the device.Therefore, the investigation is confirmed for the reported peeling as the balloon coating was noted to be delaminating off the device.The investigation is unconfirmed for the reported break, as no break was seen to the device.The user was likely referring to the peeling balloon coating in the reported event.The definitive root cause was determined to be likely manufacturing related.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h6 (device, 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 014
• 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: 23404925
• Report Number: 2020394-2025-01796
• Device Sequence Number: 20059094
• Product Code: LIT
• UDI-Device Identifier: 00801741064586
• UDI-Public: (01)00801741064586(11)240627(17)270531(10)CMJT0036
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 03/19/2026

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: U4150530
• Device Lot Number: CMJT0036
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 03/18/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/30/2025; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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