MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; VALVULOPLASTY BALLOON CATHETER

Catalog Number	0254513
Medical Device Problem Codes	Leak/Splash (1354); Peeled/Delaminated (1454); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
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 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) 2026, a patient underwent a valvuloplasty procedure.It was reported that during the procedure, while the balloon was inside the patient, the physician observed a small leak near the shoulder of the balloon.The device was immediately removed, inspected, and subsequently bagged for return.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: received one true pta dilatation catheter.Upon, visual evaluation, no kinks noted to the catheter shaft, no anomalies to the y body.On functional testing, negative pressure was applied to the balloon with an inhouse presto inflation device.With the same in house presto inflation device, the balloon was inflated and water was noted leaking from the proximal end of the balloon.Peeled pebax, fiber disturbance was noted to the fibers, balloon was cut to observe any holes within the inner guidewire lumen or catheter shaft, but no holes were noted.After further testing it was not possible to determine the source of the leak.Therefore, the investigation is confirmed for the reported leak as water was noted leaking from the proximal end of the balloon.Also, the investigation is confirmed for the identified peeled and deformation as peeled pebax and fiber disturbance were noted to the balloon.A definitive root cause for the reported leak and identified peeled / delaminated and 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.D4 (unique identifier (udi) #), g3, h6 (device, component, method, result, conclusion).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) 2026, a patient underwent valvuloplasty procedure.It was reported that during the procedure, while the balloon was inside the patient, the physician observed a small leak near the shoulder of the balloon.The device was immediately removed, inspected, and subsequently bagged for return.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: TRUE DILATATION CATHETER
• Common Device Name: VALVULOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24312561
• Report Number: 2020394-2026-00240
• Device Sequence Number: 11997390
• Product Code: OZT
• UDI-Device Identifier: 00801741097461
• UDI-Public: (01)00801741097461(11)250212(17)280128(10)GFKN0857
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150667
• 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,Followup
• Report Date (Section B): 05/29/2026

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: 0254513
• Device Lot Number: GFKN0857
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 05/11/2026; 06/09/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 05/15/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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