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	Hemorrhage/Blood Loss/Bleeding (1888); Restenosis (4576); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/28/2024
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.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.
Event or Problem Description
It was reported through results of a clinical trial that six months and twenty days post an index procedure using a drug-coated balloon catheter, the subject allegedly developed adverse event of persistent bleeding in arteriovenous fistula which required additional intervention.Reportedly, the adverse event relatedness to device, procedure, and av access circuit were not provided.The current status of the patient was unknown.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as death.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.H10: g3.H11: b2, b5, h1, h6 (patient).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 results of a clinical trial that six months and twenty days post an index procedure using a drug-coated balloon catheter, the subject allegedly developed adverse event of persistent bleeding in arteriovenous fistula which required additional intervention.Reportedly, the adverse event relatedness to device, procedure, and arteriovenous access circuit were not provided.It was further reported that the subject underwent re-intervention for prolonged bleeding and standard percutaneous transluminal angioplasty was used in re-intervention that involved on the target lesion with initial stenosis of sixty percent and final residual stenosis of ten percent.Approximately eight months and thirteen days post index procedure, the subject was expired and the cause of death information were not provided.
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.No device deficiencies were reported.Based on the available information, the investigation is inconclusive as no device deficiencies were reported and the relationship of the device to the patient bleeding and death was not reported.Based upon the available information, a definitive root cause could not be determined.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (method).H11: d4 (unique identifier (udi) #), h6 (patient).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 results of a clinical trial that six months and twenty days post an index procedure using a drug-coated balloon catheter, the subject allegedly developed adverse event of persistent bleeding in arteriovenous fistula which required additional intervention.Reportedly, the adverse event relatedness to device, procedure, and arteriovenous access circuit were not provided.It was further reported that the subject underwent re-intervention for prolonged bleeding and standard percutaneous transluminal angioplasty was used in re-intervention that involved on the target lesion with initial stenosis of sixty percent and final residual stenosis of ten percent.Approximately eight months and thirteen days post index procedure, the subject was expired and the cause of death information were not provided.
Event or Problem Description
It was reported through results of a clinical trial that six months and twenty days post an index procedure using a drug-coated balloon catheter, the subject allegedly developed adverse event of persistent bleeding in arteriovenous fistula which required additional intervention.Reportedly, the adverse event relatedness to device, procedure, and arteriovenous access circuit were not provided.It was further reported that the subject underwent re-intervention for prolonged bleeding and standard percutaneous transluminal angioplasty was used in re-intervention that involved on the target lesion with initial stenosis of sixty percent and final residual stenosis of ten percent.Approximately, eight months and thirteen days post an index procedure, the subject was expired due to cardiac arrest.Reportedly, the death was not related to device, procedure and av access circuit.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.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.No device deficiencies were reported.Based on the available information, the investigation is inconclusive as no device deficiencies were reported and the relationship of the device to the patient bleeding and death was not reported.Based upon the available information, a definitive root cause could not be determined.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.

• 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: 20543258
• Report Number: 3006513822-2024-00075
• Device Sequence Number: 15318337
• Product Code: PRC
• UDI-Device Identifier: 00801741135460
• UDI-Public: (01)00801741135460(11)230721(17)250612(10)GFHR0974
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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
• Report Date (Section B): 03/21/2025

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): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 02/05/2025; 03/12/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 01/02/2025; 02/18/2025; 04/01/2025
• 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: Death; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 150 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American