MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER; DRUG COATED BALLOON 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	12/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the device history record (dhr) review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.A lot history review revealed one (1) additional complaint involving reocclusion associated with this lot.The device history record (dhr) indicates the lot was manufactured to specification.Investigation summary: the sample was not returned by the user 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 the core lab analysis was performed and identified reocclusion.The patient received a vascular bypass.However, the lack of further information and the returned sample prevents both confirmation of the reported event and identification of a root cause(s).Label review: the review of the ifu (instructions for use), the occurrence of reocclusion is a potential adverse event with peripheral catheterization procedure and has been reported in clinical trials of drug coated balloons.
Event or Problem Description
It was reported through the results of a clinical trial, approximately 22 days post index procedure, core lab analysis was performed and identified reocclusion of the target lesion in the proximal and mid superficial femoral artery (sfa).It was further reported that a revascularization, involving a vascular bypass was performed.The sample was discarded by the user facility and is not available for evaluation.The outcome was resolved and recovered.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8754968
• Report Number: 3006513822-2019-00096
• Device Sequence Number: 11244298
• Product Code: ONU
• UDI-Device Identifier: 00801741123221
• UDI-Public: (01)00801741123221
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2021
• Device Model Number: 9004
• Device Catalogue Number: LX3513051005F
• Device Lot Number: GFCQ1684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/02/2019
• 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: 71 YR
• Patient Weight: 65