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

Model Number	9014
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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 (prc; onu).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
A patient underwent a drug coated angioplasty procedure using the lutonix 018 drug coated dilatation catheter.During the procedure the balloon was allegedly failed to deflate.Reportedly there was difficulty in retracting the device through the introducer sheath.And the balloon and catheter also got attached to the wire, requiring wire to be cut.There was no reported patient injury.
Event or Problem Description
A patient underwent a drug coated angioplasty procedure using the lutonix 018 drug coated dilatation catheter.During the procedure the balloon was allegedly failed to deflate.Reportedly there was difficulty in retracting the device through the introducer sheath.And the balloon and catheter also got attached to the wire, requiring wire to be cut.There was no reported patient injury.
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 evaluation, it was noted the catheter was received in two segments.The y-body was detached from the main catheter with the strain relief still attached.The second segment was the balloon and catheter loaded over an unknown guidewire.It was noted the balloon was bunched throughout its length, the inner gw lumen was twisted within the balloon and on the proximal end of the balloon.Due to the condition of the returned device such as detachment, functional testing cannot be performed for deflation issue or difficult to remove.Therefore, the investigation is inconclusive for the reported deflation issue as no functional testing was performed due to the condition of the device received.The investigation is confirmed for the reported difficult to remove and identified material deformation as balloon was noted to be bunched, and inner guidewire lumen was twisted within the balloon, which could have caused difficulty in removing the device through the sheath.A definitive root cause for the reported deflation issue, difficult to remove and identified material deformation 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.H6 (device, 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 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: 22477146
• Report Number: 3006513822-2025-00047
• Device Sequence Number: 12766356
• Product Code: PRC
• UDI-Device Identifier: 00801741177606
• UDI-Public: (01)00801741177606(17)261107(10)GFHY0422
• 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): 11/07/2025

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: LX1813051005F
• Device Lot Number: GFHY0422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 11/10/2025
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Race: White