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

Model Number 9004

Device Problem Naturally Worn (2988)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during an angioplasty procedure in the femoral artery, particulate matter from the device allegedly wore off inside of the patient.An aspiration of the peroneal artery was done to remove the material from the patient.There were no further complications to the patient.

Manufacturer Narrative

H10: manufacturing review: the lot number was not provided, therefore a device history record review could not be performed.Investigation summary: the samples were not returned by the facility for further evaluation or the unknown whitish substance provided in the customer images.The substance was not returned for analysis.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported failure could not be determined based upon the provided information.Labeling review: the instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.H10: g4,h6(method: 4110).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 an angioplasty procedure in the superficial femoral artery, particulate matter from the device allegedly wore off inside of the patient.An aspiration of the peroneal artery was done to remove the material from the patient.There were no further complications to the patient.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED PTA BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 10105066
• MDR Text Key: 195111693
• Report Number: 3006513822-2020-00015
• Device Sequence Number: 1
• Product Code: ONU
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9004
• Device Catalogue Number: UNK SFA 035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention