MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 018 DRUG COATED DILATATION CATHETER; DRUG COATED BALLOON PTA CATHETER

Model Number 9014

Device Problems Inflation Problem (1310); Material Rupture (1546); Material Deformation (2976)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one lutonix 018 drug coated balloon returned for evaluation.No specific anomalies were noted during the visual evaluation.The balloon was attempted to be inflated with an in-house presto inflation device during functional testing, but it was unsuccessful.The dried contrast within the inflation luer was observed under microscopic examination.It was further attempted to remove the contrast from the luer with the in-house tool, but it was unable to remove.No further testing was performed.Therefore, the investigation for the reported inflation issue, material deformation, and balloon rupture remains inconclusive as the functional testing couldn't be performed fully due to the dried contrast found within the inflation luer of the returned catheter, and no further testing could be performed due to the condition of the device.A definitive root cause for the reported inflation issue, material deformation, and balloon rupture could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Expiration date(expiry date: 05/2025).

Event Description

It was reported that during an angioplasty procedure, the drug coated balloon allegedly had a crimped ring.It was further reported that the balloon allegedly had a hole.There was no reported patient injury.

• Brand Name: LUTONIX 018 DRUG COATED DILATATION CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope 55428
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15957179
• MDR Text Key: 308358115
• Report Number: 3006513822-2022-00049
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741177705
• UDI-Public: (01)00801741177705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2022

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: 9014
• Device Catalogue Number: LX1813062205F
• Device Lot Number: GFGQ2676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1