MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 018 DRUG COATED DILATATION CATHETER; DRUG COATED BALLOON PTA CATHETER

Catalog Number	LX1810062205F
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H11: d2b (prc; onu).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.
Event or Problem Description
On (b)(6) 2025, during a percutaneous transluminal angioplasty (pta) procedure, the drug-coated balloon allegedly burst inside the vessel.Balloon inner shaft got stuck onto the wire, had resistance pulling out the faulty balloon.Initiated some force to pull out and ended up balloon broke apart and the distal part of the balloon was left inside.Access was lost & had to re-punctured and retrieved the segments.Decision was to use a snare to fish out the faulty piece and eventually managed to retrieve out.Subsequently, proceed with the rest of intervention with stent graft and drug-coated balloon.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one lutonix 018 drug coated balloon catheter returned for evaluation.Two photos were also provided for evaluation.Upon visual inspection, the device was returned in 3 segments.Segment 1 consists of the detached balloon.The balloon was bloody and was noted to have a longitudinal rupture along its length and the tip was noted to be prolapsed.Segment 2 consist of the detached inner guidewire lumen loaded over an unknown brand guidewire.Segment 3 consist of the outer proximal end of the detached balloon that was still attached to the outer catheter and y-body.It was noted the portion of the balloon had a circumferential rupture.No functional testing due to the condition of the device returned in multiple segments.The first photo shows the lutonix 018 balloon detached from the shaft.Blood residues were seen throughout the balloon.Catheter shaft and y-body was not visible in the provided photo.No other anomalies were noted.The second photo shows the packaging box.The lot number and catalog number in the box matches with the information available in the trackwise.Therefore, the investigation is confirmed for the reported balloon rupture as a compound rupture was noted to the balloon.Also, the investigation is confirmed for the reported detachment as the inner guidewire lumen was detached, and balloon was detached near the proximal end.The investigation is confirmed for the reported difficult to remove as the balloon was detached and prolapsed near the distal end, which could have caused difficulty in removing the device through sheath.A definitive root cause for the reported balloon rupture, detachment and difficult to remove could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, d2b (prc; onu), g2, g3, h6 (component, method, result, conclusion).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.
Event or Problem Description
On (b)(6) 2025, during a percutaneous transluminal angioplasty (pta) procedure, the drug-coated balloon allegedly ruptured at 12 atm inside the vessel.Further, the inner shaft of the balloon got stuck onto the wire and had resistance while pulling out the faulty balloon.Reportedly, the physician initiated some force to pull out and the balloon was broken apart where the distal part was left inside the patient's vessel.The access was lost and had to re-puncture to retrieve the broken segments.Decision was to use a snare to fish out the faulty piece and eventually managed to retrieve out.Subsequently, proceeded with the rest of intervention with stent graft and drug-coated balloon.The current status of the patient is unknown.

• Brand Name: LUTONIX 018 DRUG COATED 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: 21983386
• Report Number: 3006513822-2025-00031
• Device Sequence Number: 12840209
• Product Code: ONU
• UDI-Device Identifier: 00801741177422
• UDI-Public: (01)00801741177422(17)260920(10)GFHW1221
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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 Expiration Date: 09/20/2026
• Device Catalogue Number: LX1810062205F
• Device Lot Number: GFHW1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown