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

Catalog Number	U357554
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty (pta) procedure using the ultraverse 035 balloon catheter.During the procedure, the balloon was allegedly ruptured.The procedure was completed using another balloon.There was no reported patient injury.
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, a patient underwent an angioplasty (pta) procedure using the ultraverse 035 balloon catheter.During the procedure, the balloon was allegedly unable to inflate.The procedure was completed using another balloon.There was no reported patient injury.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.G3, h6 (device, component).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.
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 the balloon had slight blood residue.No anomalies were noted to the luer or y-body.During functional testing, an in-house presto inflation device was attempted to be used to inflate the device, but it was unable to be inflated.The catheter was cut and attached to a touhy-borst adapter to be inflated but was still unable to inflate.Another portion of the catheter was cut and attempted again without no success.The balloon was cut, and the proximal balloon joint was examined under magnification.It was noted the inflation lumen exit was collapsed.In addition, a bulge was noted to the inner guidewire lumen distal to the inflation lumen exit.The inflation lumen was flushed using an in-house syringe flusher in an effort to see if water would exit from lumen exit but water was not see exiting.No further functional testing was performed.Therefore, the investigation is confirmed for the reported inflation problem and identified material deformation as inflation lumen exit was collapsed, which could have caused inflating the balloon.The collapse of the inflation lumen could have caused the inflation issue.However, a definitive root cause for the reported inflation problem and identified material deformation could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labelling or use related issue, a labelling review is not required.G3, h6 (device, component, 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, a patient underwent an angioplasty (pta) procedure using the ultraverse 035 balloon catheter.During the procedure, the balloon was allegedly unable to inflate.The procedure was completed using another balloon.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: 23130508
• Report Number: 2020394-2025-01562
• Device Sequence Number: 17990513
• Product Code: LIT
• UDI-Device Identifier: 00801741092459
• UDI-Public: (01)00801741092459(17)280228(10)CMKQ0074
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• 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): 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: U357554
• Device Lot Number: CMKQ0074
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 10/24/2025; 11/27/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 11/06/2025; 12/02/2025
• 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