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

Catalog Number	U3513088
Medical Device Problem Codes	Leak/Splash (1354); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the left femoral artery, the leakage of fluid was allegedly found at the connection of the pta balloon body and the catheter when the balloon was withdrawn from the body.The procedure was completed using another device.There was no reported patient injury.
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: the physical device was not returned for evaluation.Four photos were provided and reviewed.The first photo shows the outer packaging of the ultraverse 035 device.The labeling information matches with the information available in trackwise.The ultraverse 035 device can be seen inside a transparent pacakging.The second photo shows the device.Dislodgement of the strain relief can be seen.A kink on the catheter shaft near to the strain relief can also be seen.The third photo shows the strain relief of the device which is seen dislodged.The fourth photo shows the balloon of the device.It is seen deflated.No specific anomalies noted.Therefore, the investigation is inconclusive for the reported leak as no objective evidence was provided.However, the investigation is confirmed for the identified strain relief dislodgement as dislodgement of the strain relief was seen.The investigation is also confirmed for the identified material deformation as a kink on the catheter shaft was seen.A definitive root cause for the alleged leak, identified strain relief dislodgement and identified material deformation 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.

• 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: 21197148
• Report Number: 2020394-2025-00007
• Device Sequence Number: 12638441
• Product Code: LIT
• UDI-Device Identifier: 00801741094194
• UDI-Public: (01)00801741094194(17)250831(10)CMGW0386
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/02/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: U3513088
• Device Lot Number: CMGW0386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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