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

Model Number	9014
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
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: the physical device was not returned for evaluation.One image was reviewed.The image shows an intra procedure fluoroscopic image of the leg with an inflated balloon containing contrast.No intravascular contrast is seen.There is suggestion of a discrete twist in the balloon, which is not completely shown on this image.Vessel atherosclerosis is present.However, there is suggestion of a discrete twist in the balloon, which is not completely shown on this image therefore, based on the photo review, the reported failure inflation issue and identified material twist be confirmed as the image review identifies a twist in the balloon during inflation.A definitive root cause for the reported failure inflation issue and identified material twist could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 04/2022).
Event or Problem Description
It was reported that during an angioplasty procedure in the right sfa via antigrade approach, the device allegedly twisted and had an inflation issue.There was no reported patient injury.

• Brand Name: LUTONIX 018 DRUG COATED DILATATION CATHETER
• Common Device Name: DRUG COATED PTA BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope 55428
• MDR Report Key: 11972520
• Report Number: 3006513822-2021-00032
• Device Sequence Number: 19120965
• Product Code: ONU
• UDI-Device Identifier: 00801741184727
• UDI-Public: (01)00801741184727
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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: GFES2769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other