MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. True Dilatation Catheter; Balloon Valvuloplasty Catheter

Catalog Number	0234512
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2026, a patient underwent a valvuloplasty procedure using a true balloon catheter.During the procedure, the balloon catheter could not be retracted into the sheath as intended, resulting in difficulty removing the sheath.To facilitate device retrieval, the balloon catheter was snared through a secondary sheath via contralateral femoral access and externalized through the left femoral access site.The balloon catheter was subsequently cut, and the remaining catheter shaft was extracted through the rfa sheath.The procedure was completed using another device.The patient's current status is unknown.
Additional Manufacturer Narrative
H11: h.4.Device manufacture date: unknown as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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: 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50766770
• Report Number: 2020394-2026-02550
• Device Sequence Number: 9241445
• Product Code: OZT
• UDI-Device Identifier: 00801741097454
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0234512
• Device Lot Number: GFLN2216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown