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

Model Number	9010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the sample was not returned from the user facility; therefore, device evaluations are unable to be performed.Lot history review revealed this is the only complaint for corporate lot number gfbt1683.A dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned by the facility for further evaluation.It is known that approximately 332 days post index procedure, a fistulogram indicated the target lesion was reoccluded.An angioplasty procedure was performed and it was deemed successful.The investigator assessed the reocclusion event was not related to the study device or to the index procedure, but definitely related to the av access circuit.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 approval study during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion in the right upper arm basilic vein swing point.Approximately 332 days post index procedure, reportedly fistulogram indicated the target lesion was reoccluded.Angioplasty was performed with successful result.The investigator assessed the reocclusion event was not related to the study device or to the index procedure, but definitely related to the av access circuit.

• Brand Name: LUTONIX 035 AV 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: 8901924
• Report Number: 3006513822-2019-00108
• Device Sequence Number: 290722
• Product Code: PRC
• UDI-Device Identifier: 00801741135521
• UDI-Public: (01)00801741135521
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• 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: 06/15/2019
• Device Model Number: 9010
• Device Catalogue Number: LX35751060V
• Device Lot Number: GFBT1683
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 64