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

Model Number	9004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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 percutaneous drug coated balloon angioplasty (dcb) procedure using the lutonix balloon catheter to treat a left femoral artery.During the procedure contrast agent leakage occurred in the mid-segment of the balloon, preventing further balloon expansion.The balloon and sheath were retrieved as a single unit from the body, and a new one was used to complete the procedure.Preoperatively, the operator reported the maximum burst pressure as 12 atm.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous drug coated balloon angioplasty (dcb) procedure using the lutonix balloon catheter to treat a left femoral artery.During the procedure, contrast agent leakage occurred in the mid-segment of the balloon, preventing further balloon expansion.The balloon and sheath were retrieved as a single unit from the body, and a new one was used to complete the procedure.Preoperatively, the operator reported the maximum burst pressure as 12 atm.The procedure was completed using 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: the physical device was not returned for evaluation.Four photo was provided and reviewed.The first photo shows the labeling details match with the information available in trackwise.The second photo shows the lutonix 035 catheter.The labeling details match with the information available in trackwise.Balloon appeared to be clean.Slight bend was noted to the proximal end of the balloon.No other anomalies were noted.The third and fourth photo shows the lutonix 035 device shaft was partially visible.No specific anomalies were noted.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported rupture 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 (medical device model #), 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/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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: 23002466
• Report Number: 3006513822-2025-00070
• Device Sequence Number: 8806328
• Product Code: ONU
• UDI-Device Identifier: 00801741163418
• UDI-Public: (01)00801741163418(17)280106(10)GFJX1730
• 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,Followup
• Report Date (Section B): 10/29/2025

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 Model Number: 9004
• Device Catalogue Number: LX3513052205F
• Device Lot Number: GFJX1730
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/17/2025
• 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