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

Catalog Number	U3513064
Medical Device Problem Codes	Difficult to Insert (1316); Failure to Advance (2524); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using ultraverse 035.During the procedure, after flushing the guidewire lumen and inserting the balloon, the surgeon found that the tail end of the balloon was significantly bent.An attempt was made to insert it into the sheath, but the bending became more severe during delivery.Reportedly balloon allegedly got stuck in the sheath.The surgeon then retrieved the balloon, which was close to breaking, and selected another product of the same model to complete the surgery.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.However, photos were provided for review.The investigation of the reported event is currently underway.H11: 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 a percutaneous transluminal angioplasty (pta) procedure using ultraverse 035.During the procedure, after flushing the guidewire lumen and inserting the balloon, the surgeon found that the tail end of the balloon was significantly bent.An attempt was made to insert it into the sheath, but the bending became more severe during delivery.Reportedly balloon allegedly got stuck in the sheath.The surgeon then retrieved the balloon, which was close to breaking, and selected another product of the same model to complete the surgery.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 dilatation catheter received for evaluation.Upon visual inspection, the device was received in two segments with a break on the catheter shaft.Segment 1 consists of the balloon and a portion of the catheter.It was noted there was indentations on the catheter shaft near the balloon joint.Segment 2 consists of the remaining catheter shaft of the device and y-body.As the device was returned in multiple segments, functional testing was not performed.One photo was provided and reviewed.The photo shows the ultraverse 035 device was detached into two segments.The detachment was noted near to the proximal end of the balloon.No other anomalies were noted.Therefore, the investigation is confirmed for the reported material deformation as indentations was noted on the catheter shaft near the balloon joint.Also, the investigation is confirmed for the identified detachment as device was detached into two segments.The investigation is inconclusive for the reported sheath insertion issues as functional testing could not be carried out due to the condition of the device returned.A definitive root cause for the reported sheath insertion issue, material deformation and identified detachment 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).H11: 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.

• 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: 22281442
• Report Number: 2020394-2025-00891
• Device Sequence Number: 12524498
• Product Code: LIT
• UDI-Device Identifier: 00801741093173
• UDI-Public: (01)00801741093173(17)270430(10)CMJS0121
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: U3513064
• Device Lot Number: CMJS0121
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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