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

Model Number	9014
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
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 will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2025) 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
It was reported that during an angioplasty procedure, the balloon was alleged to have a suspected hole in the balloon since balloon was not holding the pressure.The procedure was completed using another balloon.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon was alleged to have a suspected hole in the balloon since balloon was not holding the pressure.The procedure was completed using another balloon.There was no reported patient injury.
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 018 drug coated balloon catheter was received for evaluation.During visual analysis, residue was noted throughout the device.No other anomalies were observed.On functional testing, an in-house presto inflation device was used to inflate the balloon to 6atm and 15atm.Balloon inflated and maintained pressure.Further, the balloon deflated without any issue.No evidence of balloon rupture was noted.No other anomalies were observed.Therefore, the investigation is unconfirmed for the reported ballon rupture since the balloon inflated and deflated without any issue and no evidence of balloon rupture could be observed from the sample analysis.A definitive root cause for the reported balloon rupture issue 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: 07/2025).H11: d2b (prc;onu).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 018
• 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: 19613306
• Report Number: 3006513822-2024-00034
• Device Sequence Number: 6954609
• Product Code: ONU
• UDI-Device Identifier: 00801741177552
• UDI-Public: (01)00801741177552
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/16/2024

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: 9014
• Device Catalogue Number: LX1813041504F
• Device Lot Number: GFGT1989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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