MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 018 DRUG COATED BALLOON PTA CATHETER

Model Number	9014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Stenosis (2263); Thrombosis/Thrombus (4440); Restenosis (4576); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not 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.
Event or Problem Description
It was reported through the results of a clinical trial that approximately five months and thirteen days post an index procedure completion using a drug-coated balloon catheter, the subject had an adverse event of ¿pulsatile lue avf, vf 142 ml/min¿.Reportedly, relationship of the adverse event was not provided.The subject underwent av access circuit re-intervention.
Additional Manufacturer Narrative
H11: 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.D2b (prc; onu).D4 (medical device catalog #, unique identifier (udi) #), g3.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 a clinical trial that approximately five months and thirteen days post an index procedure completion using a drug-coated balloon catheter, the subject had an adverse event of "pulsatile lue avf, vf 142 ml/min".Reportedly, relationship of the adverse event was not provided.The subject underwent av access circuit re-intervention.
Event or Problem Description
It was reported through the results of a clinical trial that approximately five months and thirteen days post an index procedure completion using a drug coated balloon catheter, the subject had an adverse event of ¿stenosis segment beyond the left upper extremity fistula, small pseudoaneurysm in the avf¿.Reportedly, the adverse event was not related to device and procedure but definitely related to av access circuit.It was further reported that a standard pta and lutonix dcb was used during re intervention in the target lesion on cephalic vein with initial stenosis of 80% and final residual stenosis of 30%.The re intervention was successful and no new access was provided.It was reported through the results of a clinical trial that approximately eleven months and two days later post the procedure it was reported that avf pulsatile and has poor flow.There was no reported patient injury.It was reported through the results of a clinical trial that approximately eleven months and two days post an index procedure completion using a drug coated balloon catheter, the subject had an adverse event of ¿thrombosed avf¿.Reportedly, adverse event was possible related to the device, definitely related to the av access circuit but not related to the procedure.It was further reported that a standard pta and other dcb was used during re intervention in the target lesion on cephalic vein with initial stenosis of 80% and final residual stenosis of 30%.The re intervention was successful, and no new access was provided.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.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.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D2b (prc; onu), b5, g3, h6 (patient, method).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 a clinical trial that approximately five months and thirteen days post an index procedure completion using a drug coated balloon catheter, the subject had an adverse event of "stenosis segment beyond the left upper extremity fistula, small pseudoaneurysm in the avf".Reportedly, the adverse event was not related to device and procedure but definitely related to av access circuit.It was further reported that a standard pta and lutonix dcb was used during re intervention in the target lesion on cephalic vein with initial stenosis of 80% and final residual stenosis of 30%.The re intervention was successful and no new access was provided.It was reported through the results of a clinical trial that approximately eleven months and two days post an index procedure completion using a drug coated balloon catheter, the subject had an adverse event of "thrombosed avf".Reportedly, adverse event was possible related to the device, definitely related to the av access circuit but not related to the procedure.It was further reported that a standard pta and other dcb was used during re-intervention in the target lesion on cephalic vein with initial stenosis of 80% and final residual stenosis of 30%.Additional information was received, stating that subject had adverse event cephalic vein stenosis.The adverse event was possibly related to device, not related to procedure and definitely related to av access circuit.The re intervention was successful.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.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 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.

• Brand Name: LUTONIX 018 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: 22729465
• Report Number: 3006513822-2025-00057
• Device Sequence Number: 18389910
• Product Code: ONU
• UDI-Device Identifier: 00801741177712
• UDI-Public: (01)00801741177712
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/27/2026

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: 9014
• Device Catalogue Number: LX181307405F
• Device Lot Number: UNKNOWN
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 03/06/2026; 04/24/2026
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 11/11/2025; 03/11/2026; 04/28/2026
• 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: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American