MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION 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	Thrombosis/Thrombus (4440)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial that one year and twenty-five days post index procedure using a drug coated balloon catheter in the cephalic vein, the subject developed serious adverse event of occlusion due to thrombosis of the cephalic vein which required an additional surgical intervention.It was further reported that one year one month and one day after index procedure, the access thrombosis in the right upper arm cephalic vein had hundred percent initial stenosis and zero percent final residual stenosis.It was also reported that the subject underwent thrombectomy and surgical revision of right upper extremity thrombosed arteriovenous fistula with six-millimeter artegraft as an interposition graft to restore blood flow to that original arteriovenous fistula.The reintervention was not successful, and so a new arteriovenous graft access was surgically created, and the outcome was recovered.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 (expiry date: 10/2024).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 : device not returned.
Event or Problem Description
It was reported through the results of a clinical trial that one year and twenty-five days post index procedure using a drug coated balloon catheter in the cephalic vein, the subject developed a serious adverse event of occlusion due to thrombosis of the cephalic vein which required additional arteriovenous access circuit re-intervention.It was further reported that one year, one month, and one day after the index procedure, the access thrombosis in the right upper arm cephalic vein had a hundred percent initial stenosis and zero percent final residual stenosis.Furthermore, it was also reported that the subject underwent thrombectomy and surgical revision of right upper extremity thrombosed arteriovenous fistula with six-millimeter artegraft as an interposition graft to restore blood flow to that original arteriovenous fistula.The re-intervention was not successful, and so a new arteriovenous graft access was surgically created, and the outcome was recovered.The patient's current status 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: b5, d4 (expiry date: 10/2024).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.

• Brand Name: LUTONIX 035 DRUG COATED PTA DILATATION 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: 17630269
• Report Number: 3006513822-2023-00030
• Device Sequence Number: 12673750
• Product Code: PRC
• UDI-Device Identifier: 00801741135422
• UDI-Public: (01)00801741135422
• 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): 10/25/2023

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: LX3575740V
• Device Lot Number: GFFU2997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/26/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander