MAUDE Adverse Event Report: Lutonix, Inc Lutonix 035AV Drug Coated PTA Dilation Catheter; 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	Encephalopathy (1833); Stenosis (2263); Restenosis (4576)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
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 had stenosis on the target vein.The current status of the patient was unknown.
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 had stenosis on the target vein.The current status of the patient was unknown.
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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labelling 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 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 clinical trial (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 had stenosis on the target vein.It was further reported that the patient had an adverse event of encephalopathy.The relationship of the event with the device, procedure, or av access circuit intervention was not reported.The event did not result in a re-intervention.However, the current status of the patient was unknown.
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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, h6 (patient).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 clinical trial (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 had stenosis on the target vein.It was further reported that the patient had an adverse event of left arteriovenous fistula outflow stenosis.The relationship of the event with the device, procedure is not related but definitely related to the av access circuit.The event did result in a re-intervention with initial stenosis percent of fifty and final residual stenosis of forty.However, the current status of the patient was unknown.
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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.

• Brand Name: Lutonix 035AV Drug Coated PTA Dilation Catheter
• Common Device Name: Drug Coated Balloon PTA Catheter
• Manufacturer (Section D): Lutonix, Inc; 9409 science center dr; new hope 55428
• 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: 22661990
• Report Number: 3006513822-2025-00056
• Device Sequence Number: 14381589
• Product Code: PRC
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/30/2026

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 Expiration Date: 06/06/2025
• Device Model Number: 9010
• Device Catalogue Number: LX35751040V
• Device Lot Number: GFJQ1851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/12/2025; 01/26/2026; 08/01/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/04/2025; 01/28/2026; 08/06/2026
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 129 LB
• Patient Race: White