MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 018; DRUG COATED BALLOON PTA CATHETER

Model Number	9014
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.D2b: (onu; prc).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
On (b)(6)2025, a patient underwent a percutaneous drug coated balloon angioplasty (dcb) procedure using the lutonix drug coated dilatation catheter.During the preparation upon removal from package it was noted that the balloon was detached from the catheter.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one lutonix 018 drug coated balloon catheter returned for evaluation.Upon visual inspection, it was noted the device was received in two segments.Segment 1 consists of the detached balloon and a portion of the inner gw lumen extending out from the break.The segment was returned with the balloon protector over the balloon.The balloon protector was removed and under microscopic examination, a circumferential break was noted on the inflation lumen.Segment 2 consist of the other portion of the catheter break attached to the luers and y-body.No functional testing was performed due to the condition of the device received.Therefore, the investigation is confirmed for the reported detachment issue as a device was received in two segments.A definitive root cause for the reported detachment of device could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D2b: (onu; prc), g3, h6 (component, method, result, conclusion) 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
On (b)(6) 2025, a patient underwent a percutaneous drug coated balloon angioplasty (dcb) procedure using the lutonix drug coated dilatation catheter.During preparation, upon removal from the package, it was noted that the balloon was detached from the catheter.There was no patient contact.

• Brand Name: LUTONIX 018
• 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: 23050368
• Report Number: 3006513822-2025-00073
• Device Sequence Number: 9665652
• Product Code: ONU
• UDI-Device Identifier: 00801741177705
• UDI-Public: (01)00801741177705(17)280403(10)GFKN2882
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9014
• Device Catalogue Number: LX1813062205F
• Device Lot Number: GFKN2882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown