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

Model Number	9004
Medical Device Problem Codes	Deflation Problem (1149); Leak/Splash (1354); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
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.The investigation of the reported event is currently underway.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 or Problem Description
It was reported that during angioplasty procedure, the drug coated balloon allegedly does not deflate.It was further reported that the balloon could not be removed from the sheath.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one lutonix 035 drug coated balloon was received for evaluation.An in-house presto inflation device was used to inflate the balloon, which inflated and maintained pressure where the balloon did not fully deflate.Further, on second attempt to inflate the balloon, water was noted to be leaking from the inflation luer.After the balloon was fully deflated on the second attempt, the sheath was retrieved from the balloon.An in-house guidewire was also advanced through the guidewire lumen, and resistance was encountered at the kinked region.Minimal saline residue was noted on the guidewire.No further testing was performed.Therefore, the investigation is confirmed for the reported deflation issue as the balloon did not deflate fully.Also, the investigation is confirmed for the identified leak as a leak was noted from inflation leur.However, the investigation is unconfirmed for the reported sheath removal difficulty as the sheath was retrieved from the balloon successfully.A definitive root cause for the alleged deflation issue, sheath removal difficulty and identified leak 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.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 or Problem Description
It was reported that during angioplasty procedure, the drug coated balloon allegedly does not deflate.It was further reported that the balloon could not be removed from the sheath.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA 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: 19980579
• Report Number: 3006513822-2024-00049
• Device Sequence Number: 12855893
• Product Code: ONU
• UDI-Device Identifier: 00801741123320
• UDI-Public: (01)00801741123320(11)240126(17)261130(10)GFHY0429
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• 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,Followup
• Report Date (Section B): 12/02/2024

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: 9004
• Device Catalogue Number: LX351307605F
• Device Lot Number: GFHY0429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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