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

Model Number	9014
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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 was performed.The return of the sample is pending.However, an image was provided for review.The investigation of the reported event is currently underway.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, 86-year-old male patient underwent an angioplasty procedure in superficial femoral artery/popliteal artery via contralateral approach using the lutonix 018 drug coated dilatation catheter in which the balloon allegedly got twisted in 2 areas and trouble deflating.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one x-ray image was provided and reviewed.The image provided shows a balloon that has been inflated within the superficial femoral artery.The balloon has contrast throughout the length of the balloon, however, in two locations the balloon has not completely inflated.These are tight focal narrowing's.One catheter returned for evaluation.Upon visual inspection, it was noted that the balloon was received partially inflated with liquid inside.Throughout the length of the balloon there was portions of the balloon folding over itself.However, there was two specific points of twisting as it had striations when straightened out.During functional testing, an in-house inflation device was used to inflate the device to nominal pressure.The balloon was successfully inflated and maintained pressure.It was noted the balloon straightened and did not revert back to twisting, but the inner gw lumen had an s shape.The balloon was then inflated to rbp and was able to maintain pressure and shape.The inner gw lumen straightened out at this pressure.Then the balloon was deflated, and the balloon deflation time was approximately 27 seconds.No further functional testing was performed.Although the balloon was inflated and deflated without any issues, the investigation is confirmed for the reported material twist upon inflation as striation marks and twisting was noted on the balloon.The investigation is unconfirmed for the reported deflation issue as the balloon was deflated within specified time.A definitive root cause for the reported twist upon inflation issue and deflation issue 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, h6 (device, 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, 86-year-old male patient underwent an angioplasty procedure in superficial femoral artery/popliteal artery via contralateral approach using the lutonix 018 drug coated dilatation catheter in which the balloon allegedly got twisted in 2 areas and trouble deflating.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: LUTONIX 018 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: 22881927
• Report Number: 3006513822-2025-00065
• Device Sequence Number: 9631354
• Product Code: ONU
• UDI-Device Identifier: 00801741184727
• UDI-Public: (01)00801741184727(11)250423(17)280313(10)GFJZ0302
• Combination Product (Y/N): Y
• Initial Reporter State: DE
• 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): 11/24/2025

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: LX1813063005F
• Device Lot Number: GFJZ0302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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 Age: 86 YR
• Patient Sex: Male
• Patient Weight: 87 KG