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

Catalog Number	0234512
Medical Device Problem Codes	Deflation Problem (1149); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a valvuloplasty procedure, it was reported that during the preparation of a true balloon, allegedly found it could not be deflated.Further, air bubbles were coming out of the catheter all the time.The procedure was completed using another device.There was no patient contact.
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 a valvuloplasty procedure, it was reported that during the preparation of a true balloon, allegedly found it could not be deflated.Further, air bubbles were coming out of the catheter all the time.The procedure was completed using another device.There was no patient contact.
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, upon visual inspection, no anomalies were noted to the balloon or the y-body.During functional testing, the device gw lumen was flushed using an in-house syringe.The patency of the guidewire lumen was tested using an in-house guidewire, and it was able to be inserted without issues.An in-house presto inflation device and in-house stopcock were used to inflate the balloon.The balloon inflated and maintained pressure; the balloon was then inflated to rbp and was able to maintain pressure and shape.No leaking or rupture was noted on the balloon or catheter shaft.The balloon was deflated without issue.No other functional testing performed.Therefore, the investigation is unconfirmed for the reported deflation issue and air in device as the balloon was deflated without issue.A definitive root cause for the reported deflation issue and air or gas in device 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 (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 or reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: TRUE DILATATION 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: 23894831
• Report Number: 2020394-2025-02250
• Device Sequence Number: 17478881
• Product Code: OZT
• UDI-Device Identifier: 00801741097454
• UDI-Public: (01)00801741097454(17)280728(10)GFKT2268
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Report Date (Section B): 02/13/2026

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: 0234512
• Device Lot Number: GFKT2268
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/17/2026
• 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