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	Aneurysm (1708); Restenosis (4576)
Date of Event	12/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial that approximately two weeks five days post index procedure using a drug-coated balloon catheter in the cephalic vein, the subject had an adverse event of left upper extremity avf malfunction and target limb left upper extremity fistulogram with revision.Reportedly, the adverse event was possibly related to study device and study procedure and definitely related to av access circuit.It was further reported that the subject underwent av access circuit re-intervention in the target lesion on left upper arm for elevated venous pressure.Furthermore, a drug coated balloon and surgical revision of left cephalic venoplasty was performed during re-intervention on the target lesion with initial stenosis of 50% and final residual stenosis of 40%.Reportedly, the re-intervention was successful and the current status of the patient was unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records was 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.H11: section a through f - the information provided by bd represents all of 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.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.G3, h6 (method, component).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 two weeks five days post index procedure using a drug-coated balloon catheter in the cephalic vein, the subject had an adverse event of left upper extremity avf malfunction and target limb left upper extremity fistulogram with revision.Reportedly, the adverse event was possibly related to study device and study procedure and definitely related to av access circuit.It was further reported that the subject underwent av access circuit re-intervention in the target lesion on left upper arm for elevated venous pressure.Furthermore, a drug coated balloon and surgical revision of left cephalic venoplasty was performed during re-intervention on the target lesion with initial stenosis of 50% and final residual stenosis of 40%.Reportedly, the re-intervention was successful and the current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.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.
Event or Problem Description
It was reported through the results of a clinical trial that approximately two weeks five days post index procedure using a drug-coated balloon catheter in the cephalic vein, the subject had an adverse event of left upper extremity avf malfunction and target limb left upper extremity fistulogram with revision.Reportedly, the adverse event was possibly related to study device and study procedure and definitely related to av access circuit.It was further reported that the subject underwent av access circuit re-intervention in the non-target lesion on left upper arm for elevated venous pressure.Furthermore, a drug coated balloon and surgical revision of left cephalic venoplasty was performed during re-intervention on the non-target lesion with initial stenosis of 90% and final residual stenosis of 40%.Reportedly, the re-intervention was successful and the current status of the patient was unknown.Furthermore, approximtely six months and one week post index procedure, the subject had an ulcerated aneurysm and a surgical revision - left cephalic avf aneurysmorrhaphy and cephalic turndown revision was performed on the patient for a non-target lesion with initial stenosis% of100% and final residual stenosis% of 0%.Reportedly, the re-intervention was successful and the current status of the patient was unknown.

• 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 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: 21823089
• Report Number: 3006513822-2025-00025
• Device Sequence Number: 11834351
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2025

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: 03/14/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 10/15/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 06/19/2025; 10/29/2025
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic
• Patient Race: White