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

Model Number	9014
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 catheter was returned for evaluation.Wrinkles were noted over the returned balloon, no other anomalies noted during visual evaluation.On the functional testing, the returned device was inflated to 6 atm, and as the balloon was in an inflated condition, a deformation was noted over the balloon.No other functional testing was performed.All the anomalies were noted under microscopic observation.Two radiographic images was reviewed.Two images of a 150 length 6mm diameter drug coated balloon.This shows the balloon with a focal waist in both images.The waist is in different locations within the balloon if this is the same balloon used in both images, it appears the balloon did not completely inflate with a focal waist.The investigation was confirmed for the reported abnormal inflation and identified a balloon twist as a wrinkle that was noted over the balloon during visual evaluation, and the deformity was also noted on the balloon upon inflation with the retuned device.All these anomalies were also confirmed during the radiographic image review.A definitive root cause for the reported abnormal inflation and identified a balloon twist could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Expiry date: 05/2025.
Event or Problem Description
It was reported that during an angioplasty procedure, the drug coated balloon allegedly failed to inflate.It was further reported that the balloon was allegedly deformed.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 catheter was returned for evaluation.Wrinkles were noted over the returned balloon, no other anomalies noted during visual evaluation.On the functional testing, the returned device was inflated to 6 atm, and as the balloon was in an inflated condition, a deformation was noted over the balloon.No other functional testing was performed.All the anomalies were noted under microscopic observation.Two radiographic images was reviewed.Two images of a 150 length 6mm diameter drug coated balloon.This shows the balloon with a focal waist in both images.The waist is in different locations within the balloon if this is the same balloon used in both images, it appears the balloon did not completely inflate with a focal waist.The investigation is confirmed for the reported abnormal inflation and identified balloon twist as a wrinkle was noted over the balloon during visual evaluation, and the deformity was also noted on the balloon upon inflation with the retuned device.All these anomalies were also confirmed during the radiographic image review.A definitive root cause for the reported abnormal inflation and identified a balloon twist could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: (expiry date: 05/2025).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 failed to inflate.It was further reported that the balloon was allegedly deformed.The procedure was completed using another device.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: 16407365
• Report Number: 3006513822-2023-00007
• Device Sequence Number: 15002898
• Product Code: ONU
• UDI-Device Identifier: 00801741177699
• UDI-Public: (01)00801741177699
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/07/2023

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: LX1813061505F
• Device Lot Number: GFGQ2727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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