MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number	9004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed three (3) reocclusion complaints were associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Investigation summary: the sample was not returned by the facility for further evaluation.The root cause could not be determined based upon the available information received from the post market clinical registry.It is known that the patient¿s left sfa was reportedly reoccluded via dus imaging and a revascularization was performed.The investigator assessed that the event was possibly related to the study device, but not related to the procedure.Label review: based on the instructions for use (ifu), the occurrence of reocclusion is an inherent risk of any pta procedure, and has been reported in clinical trials of drug coated balloons.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.
Event or Problem Description
It was reported through a post market clinical study that during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left femoral artery.It was further reported that approximately 11-month post index procedure, the patient's target lesion was reportedly reoccluded via duplex ultrasound (dus) imaging.Reportedly, a revascularization was performed with a successful result.The investigator assessed that the event was possibly related to the study device, but not related to the procedure.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8782718
• Report Number: 3006513822-2019-00098
• Device Sequence Number: 1889716
• Product Code: ONU
• UDI-Device Identifier: 00801741123153
• UDI-Public: (01)00801741123153
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 02/13/2020
• Device Model Number: 9004
• Device Catalogue Number: LX351304805F
• Device Lot Number: GFBP2536
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 46