MAUDE Adverse Event Report: LUTONIX, INC. LUTONIX® DRUG COATED BALLOON; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	LX351306805F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of coronary artery disease and peripheral vascular disease in the right lower extremity.While having a right lower extremity angiogram/angioplasty, the wire of the lutonix 035 would not pass through the balloon.Device removed without known harm to the patient, discharge the same day.

• Brand Name: LUTONIX® DRUG COATED BALLOON
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): LUTONIX, INC.; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 16627221
• Report Number: 16627221
• Device Sequence Number: 17460169
• Product Code: ONU
• UDI-Device Identifier: 00801741126888
• UDI-Public: (01)00801741126888(17)230406(10)GFEQ3692
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/10/2020
• Report Date (Section F): 11/10/2020

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: LX351306805F
• Device Catalogue Number: LX351306805F
• Device Lot Number: GFEQ3692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 74 KG
• Date Report Sent to FDA: 11/10/2020