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

Model Number LX3513042205F

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2020

Event Type  malfunction  

Event 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
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): LUTONIX, INC.; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9744694
• MDR Text Key: 180568582
• Report Number: 9744694
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741163401
• UDI-Public: (01)00801741163401
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LX3513042205F
• Device Catalogue Number: LX3513042205F
• Device Lot Number: GFDR0566
• 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: 02/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 58