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

Model Number	LX1813053005F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device wouldn't advance through sheath for a second pass.New catheter opened and worked.No patient injury.

• Brand Name: LUTONIX® DRUG COATED BALLOON
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): C.R. BARD, INC.; 289 bay rd.; queensbury NY 12804
• MDR Report Key: 16815218
• Report Number: 16815218
• Device Sequence Number: 17566538
• Product Code: ONU
• UDI-Device Identifier: 00801741184710
• UDI-Public: 00801741184710
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/19/2023
• Report Date (Section F): 04/19/2023

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 Model Number: LX1813053005F
• Device Catalogue Number: LX1813053005F
• Device Lot Number: GFGX1389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2023
• 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: Unknown
• Date Report Sent to FDA: 04/19/2023