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

Model Number LX3513051205F

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/02/2021

Event Type  malfunction  

Event Description

Unknown.Manufacturer response for balloon angioplasty, bard (per site reporter).Pending.

• 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: 12413928
• MDR Text Key: 269586971
• Report Number: 12413928
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2021

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: LX3513051205F
• Device Catalogue Number: LX3513051205F
• Device Lot Number: GFEV0432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Weight: 83