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	Thrombosis/Thrombus (4440); Restenosis (4576)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial that three months and seventeen days post an index procedure completion using a drug coated balloon catheter in the cephalic vein, the subject developed a serious adverse event of vascular occlusion due to access thrombosis which required an additional arteriovenous access circuit reintervention.Thrombectomy and fistula ligation were performed to treat access thrombosis.Treatment re-intervention was not successful due to abandoned access.Furthermore, a new access was created using permanent dialysis catheter due to reassessment need for central venous catheter.Reportedly, there have been no documented device deficiencies reported for this subject to date.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: 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.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.H10: d4 (expiration date: 06/2025).H11: 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.H3 other text : device not returned.
Event or Problem Description
It was reported through the results of a clinical trial that three months and seventeen days post an index procedure completion using a drug coated balloon catheter in the cephalic vein, the subject developed a serious adverse event of vascular occlusion due to access thrombosis, target lesion restenosis which required an additional arteriovenous access circuit reintervention.Thrombectomy and fistula ligation were performed to treat access thrombosis.Treatment re-intervention was not successful due to abandoned access.Furthermore, a new access was created using permanent dialysis catheter due to reassessment need for central venous catheter.Reportedly, there have been no documented device deficiencies reported for this subject to date.Av access circuit re-intervention was performed for creation of right arm radiocephalic fistula, for creation of permanent access, due to occlusion in previous fistula.The current status of the patient is unknown.
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.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, d4 (unique identifier (udi) #), h6 (patient, component, 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.

• 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: 18867449
• Report Number: 3006513822-2024-00009
• Device Sequence Number: 7879609
• Product Code: PRC
• UDI-Device Identifier: 00801741135460
• UDI-Public: (01)00801741135460(11)230721(17)250612(10)GFHR0974
• Combination Product (Y/N): N
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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 Expiration Date: 06/12/2025
• Device Model Number: 9010
• Device Catalogue Number: LX3575860V
• Device Lot Number: GFHR0974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 07/13/2025
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2023
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Hispanic
• Patient Race: White