MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION 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); Stenosis (2263); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440); Restenosis (4576)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial that sometime post an index procedure completion using a drug-coated balloon catheter in the cephalic vein at outflow near cannulation zone via the left upper arm, the subject had adverse event of pseudoaneurysm on pre-dilation and aneurysm on cephalic vein.It was further reported that one month and eleven days after index procedure, the subject had serious adverse event due to cephalic vein restenosis and access circuit thrombosis which required an arteriovenous access circuit reintervention.Furthermore, one month and nineteen days after index procedure, standard percutaneous transluminal angioplasty procedure was performed to treat cephalic vein restenosis and access circuit thrombosis.Treatment reintervention was successful, new access was not created, and the outcome of the serious adverse event was resolved.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: 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: 05/2025) 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.
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.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 sometime post an index procedure completion using a drug-coated balloon catheter in the cephalic vein at outflow near cannulation zone via the left upper arm, the subject had adverse event of pseudoaneurysm on pre-dilation and aneurysm on cephalic vein.It was further reported that one month and eleven days after index procedure, the subject had serious adverse event due to cephalic vein restenosis and access circuit thrombosis which required an arteriovenous access circuit reintervention.Furthermore, one month and nineteen days after index procedure, standard percutaneous transluminal angioplasty procedure was performed to treat cephalic vein restenosis and access circuit thrombosis.Treatment reintervention was successful, new access was not created, and the outcome of the serious adverse event was resolved.Reportedly, there have been no documented device deficiencies reported for this subject to date.The current status of the patient is unknown.

• Brand Name: LUTONIX 035 DRUG COATED PTA DILATATION 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: 20179463
• Report Number: 3006513822-2024-00059
• Device Sequence Number: 8364233
• Product Code: PRC
• UDI-Device Identifier: 00801741135422
• UDI-Public: (01)00801741135422(11)220701(17)250523(10)GFGR0980
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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): 10/22/2024

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: 05/23/2025
• Device Model Number: 9010
• Device Catalogue Number: LX3575740V
• Device Lot Number: GFGR0980
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White