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

Model Number 9014

Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)

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

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation, however, photos were provided for review.The investigation of the reported event is currently underway.Expiry date (04/2022).

Event Description

It was reported that during a drug coated balloon angioplasty procedure through left superficial femoral artery, the device allegedly had an inflation issue, and material twisted.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one device was returned for evaluation.The balloon was noted to be twisted at the distal end.The guidewire lumen was then flushed using an in house guidewire and was noted to be advanced through the device without issues.Negative pressure was pulled and the device was then inflated using an in house presto device.The device was inflated to nominal pressure and the balloon was noted to maintain uniform shape and pressure.The device was deflated without issues and the twisted material site was not present.Therefore, the investigation is unconfirmed for the reported inflation issue, as the device was inflated and deflated without issues.The investigation is confirmed for the reported material twisting, as the device was returned with twisted material at the balloon portion.However, the definitive root cause for the reported inflation issue and material twisting 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: (expiry date: 04/2022).H11:section a through f - the information provided by bd represents all of 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 a drug coated balloon angioplasty procedure through left superficial femoral artery, the device allegedly had an inflation issue and material twisted.There was no reported patient injury.

• Brand Name: LUTONIX 018 DRUG COATED BALLOON PTA CATHETER
• Type of Device: PTA DRUG COATED BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 11044516
• MDR Text Key: 223194266
• Report Number: 3006513822-2020-20012
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741184727
• UDI-Public: (01)00801741184727
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

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: 9014
• Device Catalogue Number: LX1813063005F
• Device Lot Number: GFES2769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other