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 Twisted/Bent (2981)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2024).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 that during an angioplasty procedure, the drug-coated balloon was allegedly twisted upon inflation.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One fluoroscopic image was provided and reviewed.The image shows a balloon dilation within the superficial femoral artery.The mid balloon is not inflated with contract both proximal and distal to the non inflated portion.It demonstrates a partially twisted segment in the mid balloon.Therefore, the investigation is confirmed for the reported material twisting during inflation as twisting was noted on the balloon during dilation from the image review.A definitive root cause for the reported material twisting during inflation 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.H10: d4 (expiry date: 11/2024).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 : device not returned.

Event Description

It was reported that during an angioplasty procedure, the drug-coated balloon allegedly twisted upon inflation.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 MN 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: 17467301
• MDR Text Key: 320895131
• Report Number: 3006513822-2023-00025
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741184727
• UDI-Public: (01)00801741184727
• 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,Followup
• Report Date: 10/13/2023

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 Operator: Health Professional
• Device Model Number: 9014
• Device Catalogue Number: LX1813063005F
• Device Lot Number: GFFX0612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/06/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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