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	03/07/2019
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 this is the only complaint associated with this lot number.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 the patient's left sfa was reoccluded via dus imaging and a revascularization was performed.The procedure was deemed successful.The investigator assessed that the event was not related to the study device or procedure.However, the root cause could not be determined based upon the available information received from the post market clinical registry and the lack of a returned product analysis.Label review: based on the instructions for use (ifu), the occurrence of a reocclusion event is an inherent risks of any pta procedure, and have 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.It was further reported that approximately 10 months post 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 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: 8846426
• Report Number: 3006513822-2019-00105
• Device Sequence Number: 11249836
• Product Code: ONU
• UDI-Device Identifier: 00801741123269
• UDI-Public: (01)00801741123269
• 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): 07/31/2019

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: 05/31/2020
• Device Model Number: 9004
• Device Catalogue Number: LX351306605F
• Device Lot Number: GFBS3455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/31/2019
• 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: 70 YR
• Patient Weight: 67