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

Catalog Number	0204511
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a valvuloplasty procedure using true dilation balloon via the access site of right groin to treat the transcatheter aortic valve replacement.During the procedure, the balloon had a pinhole rupture.The procedure was completed with another device.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 true dilatation valvuloplasty catheter returned for evaluation.Upon visual inspection, it was noted the device was returned loaded within the packaging hoop.No anomalies noted to the balloon, catheter or the y-body.During functional testing, an in-house presto inflation device was used to inflate the device, and water was noted to be leaking from the proximal balloon joint.The device was examined under magnification, and a partial break was noted at the proximal glue joint.No further functional testing was performed.Therefore, the investigation is confirmed for the identified break as partial break was noted at proximal glue joint.However, the investigation is inconclusive for the reported balloon rupture as further functional testing was not performed due to the identified break.A definitive root cause for the reported balloon rupture and identified break 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.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: TRUE DILATATION BALLOON VALVULOPLASTY CATHETER
• Common Device Name: BALLOON VALVULOPLASTY 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: 23693799
• Report Number: 2020394-2025-02057
• Device Sequence Number: 9071984
• Product Code: OZT
• UDI-Device Identifier: 00801741090998
• UDI-Public: (01)00801741090998(17)280128(10)GFKN0851
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/21/2025

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: 0204511
• Device Lot Number: GFKN0851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 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