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

Model Number	9014
Medical Device Problem Codes	Failure to Advance (2524); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a drug coated balloon angioplasty procedure, the two catheters are the same exact size but were allegedly found with two different catheter lengths.It was further reported that the second balloon was a different length than the first and was also allegedly not able to reach the lesion when it should have been.Furthermore, it was confirmed that the product packaging and labels were correct; however, the catheters were allegedly in fact different lengths.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records was performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: 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
It was reported that during a drug coated balloon angioplasty procedure, the two catheters are the same exact size but were allegedly found with two different catheter lengths.It was further reported that the second balloon was a different length than the first and was also allegedly not able to reach the lesion when it should have been.Furthermore, it was confirmed that the product packaging and labels were correct; however, the catheters were allegedly in fact different lengths.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one lutonix 018 drug coated balloon received for evaluation.During visual evaluation, balloon catheter length was measured and found to be within specifications.No issues were noted to the device markings.During function testing, the patency of the guide-wire lumen was tested using an in-house guidewire, but it was unsuccessful.Heavy resistance was encountered at the distal end.The guidewire was viewed under a microscope and saline residue was noted.No further testing performed.Therefore, the investigation is inconclusive for the reported failure to advance through the lesion issue as the conditions of use could not be replicated in the laboratory.However, the investigation is unconfirmed for the reported mislabeled product as the returned sample was within the specification.A definitive root cause for the alleged mislabeled product and failure to advance 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: 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.

• 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: 20361389
• Report Number: 3006513822-2024-00066
• Device Sequence Number: 9728481
• Product Code: ONU
• UDI-Device Identifier: 00801741177651
• UDI-Public: (01)00801741177651(11)231129(17)260122(10)GFGZ1931
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 12/30/2024

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: 01/22/2026
• Device Model Number: 9014
• Device Catalogue Number: LX181306605F
• Device Lot Number: GFGZ1931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 01/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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