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

Model Number	9004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample evaluation could not be performed because the sample was discarded by the user facility.It is known that the dcb allegedly ruptured at nominal pressure while treating the patient's sfa.However, the lack of further information or the returned sample prevents both confirmation of the reported event or identification of a root cause(s).No adverse patient outcomes were reported.The root cause of the material rupture could not be determined based upon the available information received from field communications.Labeling review: ifu dw5159-01 states in section 8 "potential adverse events which may be associated with a peripheral balloon dilatation procedure lists rupture as a potential adverse event.Section 5.4 device use/ procedure precautions states: predilatation with uncoated pta catheter is required prior to use of lutonix catheter always advance and retrieve the lutonix catheter under negative pressure.Whenever possible, the lutonix catheter should be the final treatment of the vessel, however post dilatation is allowed with another pta catheter or the previously used lutonix catheter.Section 12.6 use of lutonix catheter step 4 states: while the balloon is fully deflated and under negative pressure, advance the dcb through the introducer sheath and over the wire to the site.Section 3 states the safety and effectiveness of lutonix catheter have not been established for treatment in cerebral, carotid , coronary or renal vasculature." (expiry date: 08/2020).
Event or Problem Description
It was reported that during a recanalization procedure in the superficial femoral artery, the drug coated balloon allegedly ruptured at nominal pressure.It was further reported that another device was used to complete the procedure.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 MN 55428
• MDR Report Key: 9884655
• Report Number: 3006513822-2020-00009
• Device Sequence Number: 16829537
• Product Code: ONU
• UDI-Device Identifier: 00801741122798
• UDI-Public: (01)00801741122798
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 9004
• Device Catalogue Number: LX357541505F
• Device Lot Number: GFBV4103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1