MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number 9004

Device Problems Flushing Problem (1252); Material Separation (1562); Device-Device Incompatibility (2919)

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

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 06/2023.

Event Description

It was reported during preparation on right femoral artery, the guidewire allegedly was unable to be inserted into the guide wire lumen and the catheter allegedly difficult to flush.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: one device was received for evaluation and the balloon protector was still on the device.The device was noted to material extending out from the distal tip, and a cylindrical material was able to be pulled out.The balloon protector was removed to expose the device.The separated material was pulled out from the device and was measured.No further functional evaluation could be conducted due to the condition of the device.Therefore, the investigation is inconclusive for the reported device incompatibility and difficult to flush due to the condition of the device.The investigation is confirmed for material separation, as separated cylindrical material was noted during evaluation.The definitive root cause for the material separation, device incompatibility, and difficult to flush could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 06/2023), g3 h11: h6 (result, conclusion) h11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.

Event Description

It was reported during preparation on right femoral artery, the guidewire allegedly was unable to be inserted into the guide wire lumen and the catheter was allegedly difficult to flush.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

Manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: one device was received for evaluation and the balloon protector was still on the device.The device was noted to material extending out from the distal tip, and a cylindrical material was able to be pulled out.The balloon protector was removed to expose the device.The separated material was pulled out from the device and was measured.No further functional evaluation could be conducted due to the condition of the device.Therefore, the investigation is inconclusive for the reported device incompatibility and difficult to flush due to the condition of the device.The investigation is confirmed for material separation, as separated cylindrical material was noted during evaluation.The definitive root cause for the material separation, device incompatibility, and difficult to flush could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.D4 (expiry date: 06/2023).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported during preparation on right femoral artery, the guidewire allegedly was unable to be inserted into the guide wire lumen and the catheter was allegedly difficult to flush.The procedure was completed using another device.There was no patient contact.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11357047
• MDR Text Key: 280452716
• Report Number: 3006513822-2021-00006
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741166907
• UDI-Public: (01)00801741166907
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2022

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: 9004
• Device Catalogue Number: 9090413600040
• Device Lot Number: GFET0869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 03/19/2021; 03/25/2022
• Supplement Dates FDA Received: 04/01/2021; 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other