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

Model Number	9010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial that three months and thirty days post index procedure using a drug-coated balloon catheter in the cephalic vein, the subject developed a serious adverse event of stenosis of the cephalic vein which required an additional arteriovenous access circuit reintervention.It was further reported that the new lesion within the access circuit in the left forearm was successfully treated with drug coated balloon catheter.It was also reported that six months and three days post index procedure, the subject developed a serious adverse event of stenosis of the cephalic vein which required an additional arteriovenous access circuit reintervention.Furthermore, the new lesion within the access circuit in the left forearm was successfully treated with standard percutaneous transluminous angioplasty balloon catheter.The re-intervention was successful, no new access created, and the outcome was recovered.Reportedly, there have been no documented device deficiencies reported for this subject to date.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will 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.H10: d4 (expiration date: 05/2025).H11: section a through f ¿ the information provided 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 or Problem Description
It was reported through the results of a clinical trial that three months and thirty days post an index procedure completion using a drug-coated balloon catheter in the cephalic vein, the subject developed a serious adverse event of stenosis of the cephalic vein which required an additional arteriovenous access circuit reintervention due to decreased access blood flow.Drug coated balloon catheter was used to treat decreased access blood flow.The re-intervention was successful, no new access created, and the outcome of the serious adverse was resolved.It was further reported that six months and three days post an index procedure completion, the subject developed a serious adverse event of stenosis of the cephalic vein which required an additional arteriovenous access circuit reintervention.Standard percutaneous transluminal balloon angioplasty procedure was performed to treat decreased access blood flow.The re-intervention was successful, no new access created, and the outcome of the serious adverse was resolved.It was also reported that seven months and fifteen days post an index procedure completion, the subject developed a serious adverse event of malfunctioning of left radio cephalic arteriovenous fistula which required an additional arteriovenous access circuit reintervention due to decreased access blood flow.Surgical revision was performed to treat decreased access blood flow.The re-intervention was successful; however, radial artery of the left arteriovenous fistula was significantly calcified.Furthermore, a new radio cephalic arteriovenous fistula access was created.Reportedly, there have been no documented device deficiencies reported for this subject to date.The current status of the patient is unknown.
Additional 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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 05/2025), g3, h6 (method).H11: section a through f ¿ the information provided 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.

• Brand Name: LUTONIX 035AV DRUG COATED PTA DILATION CATHETER
• Common Device Name: 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: 17859489
• Report Number: 3006513822-2023-00036
• Device Sequence Number: 5704954
• Product Code: PRC
• UDI-Device Identifier: 00801741135385
• UDI-Public: (01)00801741135385
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: 9010
• Device Catalogue Number: LX3575640V
• Device Lot Number: GFGR0983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Hispanic
• Patient Race: White