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

Model Number	9010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a patient underwent a percutaneous drug coated balloon angioplasty (dcb) procedure using the lutonix drug coated balloon catheter.During the procedure the balloon allegedly ruptured at 10 atm.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous drug coated balloon angioplasty (dcb) procedure using the lutonix drug coated balloon catheter.During the procedure, the balloon was allegedly ruptured at 10 atm.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 photo was provided and reviewed.The photo shows the labeling details of the device that match with the information available in trackwise.The lutonix 035 device kept in transparent packaging and its partially visible.Blood residues were noted throughout the balloon.No hubs were seen in the provided photo.No other anomalies were noted.One lutonix 035 drug coated balloon catheter returned for evaluation.Upon visual inspection, it was noted the balloon was bloody within the inflation lumen and the stock cock.No other anomalies were noted to the y-body.During functional testing, an in-house presto inflation device was used to inflate the balloon, during the inflation a pinhole rupture was noted to the proximal end of the balloon.The balloon inadvertently burst during inflation.No other functional testing performed.Therefore, the investigation is confirmed for the reported balloon rupture as pinhole rupture was noted to the proximal end of the balloon.A definitive root cause for the reported balloon rupture could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (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 035AV DRUG COATED PTA DILATION 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: 22383754
• Report Number: 3006513822-2025-00042
• Device Sequence Number: 8761684
• Product Code: PRC
• UDI-Device Identifier: 00801741135491
• UDI-Public: (01)00801741135491(17)261028(10)GFJV0849
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• 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): 08/22/2025

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: 9010
• Device Catalogue Number: LX3575960V
• Device Lot Number: GFJV0849
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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