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 Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
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: one lutonix 018 drug coated pta dilatation catheter has been received for the evaluation.During visual evaluation, the device appeared bloody.Under the microscopic observation, the wrinkles were noted on the balloon.No other specific anomalies were noted.On the functional evaluation, the rapid exchange port was flushed using an in-house syringe and the water successfully exited out of the distal tip.Then the guidewire was successfully advanced from the distal tip to the hub.On further negative pressure was successfully applied with an in-house presto inflation device.Then the balloon was inflated and maintained uniform shape and pressure at 6 atm.One medical image was reviewed.The image shows that the balloon appeared inflated except a very small area near the middle of the balloon and it was appeared as a napkin-ring defect.Based on the image review, the reported material twist and inflation issue can be confirmed as the middle segment of the balloon was not inflated.The investigation for the identified material twist and the reported inflation issue was confirmed as wrinkles were noted under the microscopic observation on the device returned for the evaluation.A definitive root cause for the reported inflation issue and the identified material 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.Medical device (expiry date: 09/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the device was allegedly unable to inflate.The procedure was completed using the same 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 55428
• MDR Report Key: 12215778
• Report Number: 3006513822-2021-00038
• Device Sequence Number: 1494094
• Product Code: ONU
• UDI-Device Identifier: 00801741177705
• UDI-Public: (01)00801741177705
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/16/2021

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: LX1813062205F
• Device Lot Number: GFEY0174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/23/2021
• 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
• Patient Age: 88 YR
• Patient Weight: 73