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

Catalog Number UNKNOWN LUTONIX

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/27/2021

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 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.Device not returned.

Event Description

It was reported in an article in risk of major amputation following application of paclitaxel coated balloons in the lower limb arteries, during randomized clinical trail there was eighty seven major amputations of 2216 limbs in paclitaxel arms.The details of the patient was not provided.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.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.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 through the results of a randomized clinical trial of risk of major amputation following application of paclitaxel coated balloons in the lower limb arteries, there were eighty seven major amputations out of two thousand two hundred and sixteen limbs in paclitaxel arms compared to forty one major amputations out of one thousand five hundred and forty four.The details of the patient was not provided.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.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.Konstantinos katsanos, stavros spiliopoulos, ulf teichgräber, panagiotis kitrou, costantino del giudice, patrick björkman, et al (2021).Risk of major amputation following application of paclitaxel coated balloons in the lower limb arteries: a systematic review and meta-analysis of randomised controlled trials.Eur j vasc endovasc surg, 63(1):60-71.Doi: 10.1016/j.Ejvs.2021.05.027.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 in an article in "risk of major amputation following application of paclitaxel coated balloons in the lower limb arteries", there were eighty seven major amputations out of two thousand two hundred and sixteen limbs in paclitaxel arms compared to forty one major amputations out of one thousand five hundred and forty four.The details of the patient was not provided.

• Brand Name: UNKNOWN LUTONIX
• Type of Device: DRUG COATED PTA BALLOON 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12629493
• MDR Text Key: 276351762
• Report Number: 3006513822-2021-00051
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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,Followup
• Report Date: 06/23/2022

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 Catalogue Number: UNKNOWN LUTONIX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/20/2021; 06/08/2022
• Supplement Dates FDA Received: 11/11/2021; 07/06/2022
• 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): Required Intervention