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

Catalog Number	U3575128
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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 dilatation catheter received for evaluation.During visual evaluation, the balloon was noted to be partially inflated and a kink was noted to the catheter shaft.During functional testing, an in-house presto inflation device was used to inflate the balloon, and water was noted to be leaking at the catheter shaft.Further under microscopic observations, a tear was noted to the catheter shaft where the device was leaking.No other functional testing performed.Therefore, the investigation remains inconclusive for the reported balloon rupture as further functional testing could not be performed.However, the investigation is confirmed for the identified material deformation as a kink was noted to the catheter shaft.Also, the investigation is confirmed for the identified material torn as a tear was noted to the catheter shaft.A definitive root cause for the alleged balloon rupture, identified material deformation and material torn 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.H11:section a through f - the information provided by bd represents all of 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
It was reported that during an angioplasty procedure, the pta balloon allegedly leaked when inflating it for the first time.It was further reported that the contrast was allegedly leaking.Reportedly, the balloon was safely removed from the patient.The procedure was completed using another device.There was no reported patient injury.

• 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: 21033751
• Report Number: 2020394-2024-01925
• Device Sequence Number: 4223254
• Product Code: LIT
• UDI-Device Identifier: 00801741094842
• UDI-Public: (01)00801741094842(17)261231(10)CMJN0332
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2024

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: U3575128
• Device Lot Number: CMJN0332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/30/2024
• 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