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

Model Number	9010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
H11: 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 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
It was reported through the results of the study (av pas) that sometime later post percutaneous transluminal angioplasty procedure by using lutonix dilation catheter on the basilic vein of the left upper arm for dilation of stenosis, the subject eventually expired.The cause of death was not reported and relativity of the event with the device or procedure is not reported.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.As per the provided crf, the lutonix device was used on the patient on (b)(6) 2024.No device failures or procedural issues were reported at the time of the procedure or during the 6 month follow up.The patient reportedly expired on (b)(6) 2025.Cause of death was listed as end stage renal disease.No reintervention was ever performed.However, the exact relationship between the patient death and device/procedure was not reported.Therefore, the investigation is inconclusive for the reported event.The definitive root cause for the reported event could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, d4 (unique identifier (udi) #), g3, h6 (method).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
It was reported through the results of the study (av pas) that sometime later post percutaneous transluminal angioplasty procedure by using lutonix dilation catheter on the basilic vein of the left upper arm for dilation of stenosis, the subject eventually expired, due to end stage renal disease.The cause of death was not reported and relativity of the event with the device or procedure is not reported.
Additional Manufacturer Narrative
H11: additional information was received indicating that the cause of death was not related to the device, the procedure, or the av access circuit.Therefore, the file was reassessed for reportability and determined to be no longer reportable.However, since an initial mdr was already submitted, the file will remain classified as a death.B5, g3, h6 (patient).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
It was reported through the results of the study (av pas) that, sometime after undergoing percutaneous transluminal angioplasty using a lutonix dilation catheter on the basilic vein of the left upper arm for stenosis dilation, the patient eventually expired, due to end stage renal disease.It was further reported that the death was not related to the device, the procedure, or the av access circuit.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA 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: 22975409
• Report Number: 3006513822-2025-00066
• Device Sequence Number: 21126412
• Product Code: PRC
• UDI-Device Identifier: 00801741135439
• UDI-Public: (01)00801741135439(11)240411(17)270228(10)GFHZ1709
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9010
• Device Catalogue Number: LX3575760V
• Device Lot Number: GFHZ1709
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 01/28/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 01/22/2026; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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: Death; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White