MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED PTA DILATION CATHETER; 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	04/02/2019
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.Lot history review revealed there is a total of five (5) complaints related to allegations of reocclusion for corporate lot number gfbu2005.A dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the actual sample was not returned for evaluation.It is known that approximately 7 months after the index procedure, the patient¿s left femoral artery was reportedly reoccluded via angiographic imaging.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was not related to the study device or procedure.However, the lack of further information or the returned sample prevents both confirmation of the reported event and identification of a root cause(s).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.
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.Approximately 7 months after the index procedure, the patient¿s left femoral artery was reportedly reoccluded.A revascularization was performed and the health care professional (hcp) deemed it was successful.The investigator assessed that the event was not related to the study device or procedure.

• Brand Name: LUTONIX 035 DRUG COATED PTA DILATION 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: 8902379
• Report Number: 3006513822-2019-00110
• Device Sequence Number: 11274626
• Product Code: ONU
• UDI-Device Identifier: 00801741123184
• UDI-Public: (01)00801741123184
• 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): 08/16/2019

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: Health Professional
• Device Expiration Date: 07/20/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513041505F
• Device Lot Number: GFBU2005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/16/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 44