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

Model Number	9010
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
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: one lutonix 035av drug coated balloon which was loaded along with an unknown guide wire was returned for evaluation.On the visual evaluation, bunching of catheter shaft lumen was noted near the distal end of the hub and the unknown guide was loaded into the catheter.No other anomalies were observed.On functional testing, an attempt to remove the loaded guidewire from the device, but it was unsuccessful.Furthermore, the in-house presto inflation was used to inflate the balloon from 8 atm to 12 atm, but the balloon was unable to inflate.No other functional testing.As during the visual evaluation, the catheter shaft lumen at the catheter hub was noted to be bunched and during the functional testing, the loaded guide wire was unable to remove and further the device was unable to inflate.Hence, the investigation is confirmed for both reported inflation issue and identified bunched catheter lumen and guide wire removal difficulty.During the sample evaluation, the catheter lumen near to the hub was noted to be bunched, which might contribute to the reported inflation issue.A definitive root cause for the reported inflation issues and identified bunched catheter lumen, and guide wire removal difficulty 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.H10: d4 (expiration date: 06/2024) 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.
Event or Problem Description
It was reported that during an angioplasty in the subclavian vein via the arteriovenous fistula access, the drug-coated balloon allegedly failed to inflate.The procedure was completed using another device.There was no reported patient injury.

• 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 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: 19002108
• Report Number: 3006513822-2024-00013
• Device Sequence Number: 15816908
• Product Code: PRC
• UDI-Device Identifier: 00801741202575
• UDI-Public: (01)00801741202575
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9010
• Device Catalogue Number: LX35751260V
• Device Lot Number: GFHR0975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/29/2024
• 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
• Patient Sex: Unknown