MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATION CATHETER; DRUG COATED BALLOON PTA CATHETER

Catalog Number	LX3513052205F
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
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: the physical device was not returned for evaluation.One x-ray image was provided and reviewed.The image displays a long balloon within the left superficial femoral artery.There balloon is partially within a proximal sfa stent.The balloon has been inflated with diluted contrast.The mid balloon is not inflated with a severe narrowing that appears like a band.There is contrast proximal and distal to the band.Two photos were provided and reviewed.The first photo shows the lutonix 035 balloon.Twisting was noted on the middle of the balloon.Blood residues were seen inside the balloon.Catheter hubs were not seen in the provided photo.The second photo shows the labeling details of the device that match with the information available in trackwise.No other anomalies were noted.Therefore, the investigation is confirmed for the reported uneven inflation and identified balloon twist as the mid balloon is not inflated, and twisting was noted on the middle of the balloon.Twisting observed in the balloon likely contributed to the reported uneven inflation.However, a definitive root cause for the reported uneven inflation and identified material twist 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 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 procedure using the lutonix 035 drug coated balloon (dcb) pta catheter.During the procedure, the middle part of the balloon was unable to inflate and open.It was further reported that a severe crease was found in the part that could not be inflated.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: LUTONIX 035 DRUG COATED PTA DILATION CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• 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: 22992684
• Report Number: 3006513822-2025-00069
• Device Sequence Number: 15702545
• Product Code: ONU
• UDI-Device Identifier: 00801741163418
• UDI-Public: (01)00801741163418(17)270530(10)GFJQ1850
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P130024
• 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): 08/29/2025

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: LX3513052205F
• Device Lot Number: GFJQ1850
• 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: 08/22/2025
• Initial Report FDA Received Date: 09/08/2025
• 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
• Patient Sex: Unknown