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

Model Number	9014
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review can not be performed as the batch/lot number were not provided.Investigation summary: the sample was not returned for evaluation.The allegation of a twisted balloon was confirmed through review of fluoroscopic imaging, which illustrated a portion in the middle of the balloon did not fully inflated while treating the target lesion.The root cause of the twisted balloon during inflation could not be determined based upon the available information received from field communications or returned sample analysis.Labeling review: ifu baw1436700r0 states: device use/procedure precautions states: the lutonix® catheter should be advanced to the target lesion as fast as possible (i.E.~ 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to artery ratio = 1:1).Always advance and retrieve the lutonix® catheter under negative pressure.Use of the lutonix® catheter.While the balloon is still fully deflated and under negative pressure, advance the lutonix® catheter through the introducer sheath and over the wire to the site of inflation.During catheter advancement, inspect the catheter shaft for damage.Apply negative pressure to fully deflate the lutonix® catheter.Prior to removal, confirm that the balloon is fully deflated under adequate visualization.
Event or Problem Description
It was reported that during an angioplasty procedure, the drug coated balloon allegedly twisted and could not inflate properly.There was no reported patient injury.

• Brand Name: LUTONIX 018 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9777527
• Report Number: 3006513822-2020-00002
• Device Sequence Number: 16778983
• Product Code: ONU
• UDI-Device Identifier: 00801741177705
• UDI-Public: (01)00801741177705
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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: LX1813062205F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1