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

Model Number	9014
Medical Device Problem Codes	Material Rupture (1546); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
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: one lutonix 018 was returned for evaluation.During visual inspection material twisting was noted to the balloon at distal end.An in-house presto was used to inflate the device, and a leak was noted to the proximal end of the balloon.Under microscopic observation, a longitudinal rupture was noted to the balloon.No further testing was performed.Therefore, investigation is confirmed for the reported balloon twist as material twisting was noted to the balloon.Also, the investigation is confirmed for the identified material rupture as longitudinal rupture was noted to the balloon.A definitive root cause for the reported material twist and identified material rupture 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.H11: d2b (onu; prc).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 that during an angioplasty procedure, the drug-coated balloon allegedly got wrapped.It was further reported that allegedly the same thing happened while tried to put another one.There was no reported patient injury.

• Brand Name: LUTONIX 018 DRUG COATED 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: 21580914
• Report Number: 3006513822-2025-00015
• Device Sequence Number: 15642668
• Product Code: ONU
• UDI-Device Identifier: 00801741177774
• UDI-Public: (01)00801741177774(17)260809(10)GFHU1369
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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 Expiration Date: 08/09/2026
• Device Model Number: 9014
• Device Catalogue Number: LX1813072205F
• Device Lot Number: GFHU1369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/12/2025
• 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