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

Model Number	LX3513042205F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of hypertension and atrial fibrillation.Or for right lower angiogram and angioplasty.The lutonix balloon broke and separated into two pieces while in the body.The 2 pieces of balloon were located in main shaft and the balloon portion.The wire was removed with 1 piece of balloon on it and then the sheath was taken out.The piece of balloon was removed.No injury observed to patient.

• Brand Name: LUTONIX® DRUG COATED BALLOON
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): LUTONIX, INC.; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9744694
• Report Number: 9744694
• Device Sequence Number: 10944574
• Product Code: ONU
• UDI-Device Identifier: 00801741163401
• UDI-Public: (01)00801741163401
• 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): 02/14/2020
• Report Date (Section F): 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LX3513042205F
• Device Catalogue Number: LX3513042205F
• Device Lot Number: GFDR0566
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 58
• Date Report Sent to FDA: 02/14/2020