MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 014; DRUG COATED PTA BALLOON CATHETER

Model Number 9008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Embolism/Embolus (4438)

Event Date 05/24/2022

Event Type  Injury  

Event Description

It was reported in an article in journal of ¿cardiovascular interventions¿ titled "a case of vasculitis due to distal particulate embolization after use of drug-coated balloon" approximately four months post endovascular treatment with a paclitaxel-coated balloon (bard lutonix, material# unk) for right popliteal artery and plain balloon angioplasty for below-the-knee arteries, the patient developed localized vasculitis.However, the current status of the patient is unknown.

Manufacturer Narrative

Nakamura, r., torii, s., kato, t., & kawasaki, d.(2022).A case of vasculitis due to distal particulate embolization after use of drug-coated balloon.Cardiovascular interventions, 15(14), 1486-1487.Doi: 10.1016/j.Jcin.2022.05.030 as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) 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.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Manufacturer Narrative

H10: additional information has been received and this device or similar device has not been cleared for marketing or commercial distribution in the united states.Therefore the event does not meet the criteria of a reportable event and determined to be not reportable; however, since an mdr has already been submitted, the file will remain reportable as a serious injury.H10: nakamura, r., torii, s., kato, t., & kawasaki, d.(2022).A case of vasculitis due to distal particulate embolization after use of drug-coated balloon.Cardiovascular interventions, 15(14), 1486-1487.Doi: 10.1016/j.Jcin.2022.05.030.H10: b7, d4 (expiry date: 04/2022).H11: b2, b5, d1, d4, h6 (patient) 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.H3 other text : device not returned.

Event Description

It was reported in an article in journal of ¿cardiovascular interventions¿ titled "a case of vasculitis due to distal particulate embolization after use of drug-coated balloon" approximately four months post endovascular treatment with a paclitaxel-coated balloon (bard lutonix) for right popliteal artery and plain balloon angioplasty for below-the-knee arteries, the subject developed embolism.However, the current status of the patient is unknown.

• Brand Name: LUTONIX 014
• Type of Device: DRUG COATED PTA BALLOON 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: 15517666
• MDR Text Key: 300922508
• Report Number: 3006513822-2022-00034
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741224775
• UDI-Public: (01)00801741224775
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9008
• Device Catalogue Number: LX1415041205FX
• Device Lot Number: GFDR0215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 10/27/2022
• 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
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 89 YR
• Patient Sex: Female