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	Restenosis (4576); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: 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.H10: d4 (expiration date: 08/2025).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.H3 other text : device not returned.
Event or Problem Description
It was reported through the results of the clinical trial that approximately three months fifteen days post index procedure using a drug coated balloon catheter, the subject had an adverse event of severe stenosis of anastomosis and juxta anastomotic cephalic vein and was treated with an standard percutaneous transluminal angioplasty.Reportedly the adverse event were not related to the device, procedure but definitely related to av access circuit.The re-intervention was successful, no new access created and the outcome was resolved.The current status of the patient was not provided.
Additional Manufacturer Narrative
H10: 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.H10: d4 (expiration date: 08/2025).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.
Event or Problem Description
It was reported through the results of a clinical trial that approximately three months and fifteen days post an index procedure completion using a drug coated balloon catheter, the subject had an adverse event of severe stenosis of anastomosis and juxta anastomotic cephalic vein and was treated with an standard percutaneous transluminal angioplasty.Reportedly the adverse event were not related to the device, procedure but definitely related to av access circuit.The re-intervention was successful, no new access created and the outcome was resolved.The current status of the patient was not provided.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as death.H10: date of death for this patient was not provided, date of death updated as 01-jan-1900 for the mdr submission requirement.H10: h10: 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.H10: g3, h6 (patient).H11: b5, d4 (unique identifier (udi) #).H11: 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 clinical trial that approximately three months fifteen days post an index procedure using a drug coated balloon catheter, the subject had an adverse event of severe stenosis of anastomosis and juxta anastomotic cephalic vein and was treated with an standard percutaneous transluminal angioplasty.Reportedly the adverse event were not related to the device, procedure but definitely related to av access circuit.The re-intervention involved on the target lesion with initial stenosis of 58% and final residual stenosis of 0% by standard percutaneous transluminal angioplasty and lutonix drug coated balloon.The re-intervention was successful, no new access created and the outcome was resolved.Reportedly, the subject was expired and the cause of death was not provided.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.H10: 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.H11: 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 clinical trial that three months and fifteen days post an index procedure using a drug coated balloon catheter, the subject had an adverse event of severe stenosis of anastomosis and juxta anastomotic cephalic vein and was treated with an standard percutaneous transluminal angioplasty.Reportedly, the adverse event were not related to the device, procedure but definitely related to av access circuit.The re-intervention involved on the target lesion with initial stenosis of 58% and final residual stenosis of 0% by standard percutaneous transluminal angioplasty and lutonix drug coated balloon.The re-intervention was successful, no new access created and the outcome was resolved.Reportedly, the subject was expired due to acute pulmonary edema and the death was not related to device, procedure and av access circuit.
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.Labeling 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 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 clinical trial that three months and fifteen days post an index procedure using a drug coated balloon catheter, the subject had an adverse event of severe stenosis of anastomosis and juxta anastomotic cephalic vein and was treated with an standard percutaneous transluminal angioplasty.Reportedly, the adverse event were not related to the device, procedure but definitely related to av access circuit.The re-intervention involved on the target lesion with initial stenosis of 58% and final residual stenosis of 0% by standard percutaneous transluminal angioplasty and lutonix drug coated balloon.The re-intervention was successful, no new access created and the outcome was resolved.Reportedly, the subject was expired due to acute pulmonary edema and the death was not related to device, procedure and av access circuit.

• 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: 19077767
• Report Number: 3006513822-2024-00018
• Device Sequence Number: 6271944
• Product Code: PRC
• UDI-Device Identifier: 00801741135460
• UDI-Public: (01)00801741135460(11)230922(17)250809(10)GFHT0654
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 06/13/2025

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: 08/09/2025
• Device Model Number: 9010
• Device Catalogue Number: LX3575860V
• Device Lot Number: GFHT0654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 03/24/2025; 04/14/2025; 06/13/2025
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/24/2024; 04/16/2025; 05/07/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2023
• 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: Death; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White