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

Model Number	9010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review will be performed.The device has not been returned for evaluation, therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date 01/2021).
Event or Problem Description
It was reported that during an angioplasty procedure of a lesion in the subclavian vein, the balloon allegedly ruptured after the balloon pressure was increased from 6 atm to 8 atm.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: LUTONIX DRUG COATED BALLOON
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9941488
• Report Number: 3006513822-2020-00013
• Device Sequence Number: 2320279
• Product Code: PRC
• UDI-Device Identifier: 00801741202575
• UDI-Public: (01)00801741202575
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• 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): 04/08/2020

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: LX35751260V
• Device Lot Number: GFDZ1672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 79