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

Catalog Number	U8130622
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 an angioplasty procedure using the ultraverse 018 pta balloon.During the procedure, the balloon allegedly ruptured.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 018 pta dilatation catheter returned for evaluation.Upon visual inspection, it was noted an unknown gw was returned loaded within the device.The balloon of the device was noted to be detached from the proximal end of the balloon with a small portion of the balloon remaining.The inner gw lumen was also detached and not returned.The returned gw was extending out from the site of detachment at the proximal end.No functional testing performed was performed due to the condition of the device returned.Therefore, the investigation is confirmed for the reported detachment, balloon rupture and difficult to remove as circumferential balloon rupture was noted to the balloon and inner gw lumen was noted to be detached, which could have caused difficulty in removing the balloon through sheath.However, the investigation is unconfirmed for the reported material deformation.The investigation is inconclusive for the reported deflation problem as no functional testing performed was performed due to the condition of the device returned.A definitive root cause for the reported balloon rupture, detachment, difficult to remove, deformation and deflation problem 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 (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.
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty procedure using the ultraverse 018 pta balloon.During the procedure, the balloon allegedly ruptured.The procedure was completed using another balloon.There was no reported patient injury.

• 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: 23435085
• Report Number: 2020394-2025-01820
• Device Sequence Number: 8672605
• Product Code: LIT
• UDI-Device Identifier: 00801741055409
• UDI-Public: (01)00801741055409(17)280131(10)CMKP0263
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 01/05/2026

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: U8130622
• Device Lot Number: CMKP0263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/07/2026
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 63 KG