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

Catalog Number	U357568
Medical Device Problem Codes	Leak/Splash (1354); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
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.However, images were provided for review.The investigation of the reported event is currently underway.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
On (b)(6) 2025, the patient underwent an angioplasty procedure in superficial femoral artery using the ultraverse 035 pta balloon.During the procedure, the balloon allegedly does not inflate.It was further reported that the saline solution leak was located at the joint between the catheter carrier and the hub with the luer-lock ports.The strain relief was observed to be separated from the y-body.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 dilatation catheter returned for evaluation.Upon visual inspection, it was noted there was a gap between the catheter hub and the strain relief.The distal end of the strain relief was noted to be non-concentric.The balloon was noted to have dried saline within and at the proximal end of the balloon.During functional testing, an in-house presto inflation device was used to inflate the balloon but could not be inflated due to the dried saline or possibly the narrowing.Water was not noted leaking from the strain relief.The balloon was cut, and the presto inflation device was used to pressurize the catheter in order to see if there was a leakage at the hub.However, no leakage could be seen as the device lost pressure due to the hemostats not containing the water within.Rubber strain relief was pulled back, and dried saline could be seen within the hub indicating a previous leak.No further functional testing was performed.Therefore, the investigation is confirmed for the reported leak as dried saline was seen within the hub indicating a previous leak.Also, the investigation is confirmed for the identified device dislodged as there was a gap between catheter hub and the strain relief.A definitive root cause for the reported leak and identified dislodged could not be determined based upon the provided information.It is unknown whether procedural issues contributed to the reported event.Labelling review: as the reported event did not allege a labelling or use related issue, a labelling review is not required.G3, h6 (device, method, result, conclusion) 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
On (b)(6) 2025, the patient underwent an angioplasty procedure in superficial femoral artery using the ultraverse 035 pta balloon.During the procedure, the balloon allegedly does not inflate.It was further reported that the saline solution leak was located at the joint between the catheter carrier and the hub with the luer-lock ports.The strain relief was observed to be separated from the y-body.The procedure was completed using another balloon.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DIALATION 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: 23307855
• Report Number: 2020394-2025-01687
• Device Sequence Number: 5826716
• Product Code: LIT
• UDI-Device Identifier: 00801741092978
• UDI-Public: (01)00801741092978(17)270331(10)CMJR0185
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2025

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: U357568
• Device Lot Number: CMJR0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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