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

Model Number LX351306805F

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2020

Event Type  malfunction  

Event 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
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): LUTONIX, INC.; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 16627221
• MDR Text Key: 312161691
• Report Number: 16627221
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741126888
• UDI-Public: (01)00801741126888(17)230406(10)GFEQ3692
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 11/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Male
• Patient Weight: 74 KG