MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number	9004
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Corneal Endothelial Cell Loss (4806)
Date of Event	03/06/2025
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 is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.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It was reported that during an angioplasty procedure, the drug-coated balloon was allegedly could not be withdrawn and it was withdrawn together with the guidewire.It was further reported that the balloon was allegedly wrinkled.Reportedly, the patient experienced endothelial detachment and occlusion of the dorsalis pedis artery.The current status of the patient is unknown.
Event or Problem Description
It was reported that during an angioplasty procedure, the drug-coated balloon was allegedly could not be withdrawn and it was withdrawn together with the guidewire.It was further reported that the balloon was allegedly wrinkled.Reportedly, the patient experienced endothelial detachment and occlusion of the dorsalis pedis artery.The current status of the patient is unknown.
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: the physical device was not returned for evaluation.One photo was provided and reviewed.The photo shows a healthcare professional holding the lutonix 035 balloon catheter.The balloon was wrinkled and guidewire lumen inside the balloon are noted to be bunched.No other anomalies were noted.Therefore, the investigation is confirmed for the reported material deformation and guidewire removal difficulty as the inner guidewire lumen was noted to be bunched, which may occur during guidewire removal and could have contributed to the difficulty in removing the guidewire.A definitive root cause for the reported material deformation and guidewire removal difficulty 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.G3, b5, h6 (patient, component, method, result, conclusion).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 035 DRUG COATED BALLOON PTA 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: 21759884
• Report Number: 3006513822-2025-00022
• Device Sequence Number: 20948195
• Product Code: ONU
• UDI-Device Identifier: 00801741123184
• UDI-Public: (01)00801741123184(17)250310(10)GFGP2700
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 03/10/2025
• Device Model Number: 9004
• Device Catalogue Number: LX3513041505F
• Device Lot Number: GFGP2700
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/25/2025
• 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 Sex: Unknown