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)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial that one year one month and seven days post index procedure using a drug-coated balloon catheter, in the basilic vein outflow, the subject had an adverse event of prolonged bleeding and was treated with an av access circuit reintervention.It was further reported that the adverse event relationship was not related to the device and procedure but definitely related to the av access circuit.Reportedly, standard percutaneous transluminal angioplasty and the drug coated balloon catheter were used to treat the target lesion with initial stenosis of 80% and final residual stenosis of 9%.The re-intervention was successful and the outcome was resolved.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 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 (expiry date: 10/2025).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 one year, one month, and seven days post an index procedure completion using a drug-coated balloon catheter in the basilic vein at outflow via the right upper arm, the subject allegedly had a serious adverse event of prolonged bleeding due to a hematoma which required an arteriovenous access circuit re-intervention.It was further reported that standard percutaneous transluminal angioplasty and drug-coated balloon catheter were used to treat the basilic vein restenosis with an initial stenosis of eighty percent and final residual stenosis of nine percent.Treatment re-intervention was successful and the outcome of the serious adverse event was resolved.Furthermore, one year, three months, and four days after index procedure, the subject allegedly had a serious adverse event of prolonged bleeding which required an arteriovenous access circuit re-intervention.Reportedly, other drug-coated balloon catheter was used to treat the basilic vein restenosis with an initial stenosis of eighty percent and final residual stenosis of twenty percent.Treatment re-intervention was successful and the outcome of the serious adverse event was resolved.Evidently, 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: 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.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: 20277814
• Report Number: 3006513822-2024-00062
• Device Sequence Number: 7415017
• Product Code: PRC
• UDI-Device Identifier: 00801741135392
• UDI-Public: (01)00801741135392(17)251002(10)GFGU2171
• 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
• Report Date (Section B): 10/23/2024

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: 10/02/2025
• Device Model Number: 9010
• Device Catalogue Number: LX3575660V
• Device Lot Number: GFGU2171
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/15/2024
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American