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	01/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: lot history review revealed this is the only complaint related to an allegation of reocclusion for corporate lot number gfbv4108.The 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 9 months after the index procedure, patient¿s right femoral artery was reportedly reoccluded via duplex ultrasound imaging.A revascularization was performed involving another dcb and hcp deemed it was successful.The investigator assessed that the event was not related to the study device.Furthermore, the physician thinks the selection of an under sized pre-dilation balloon, during the index procedure, due to a measurement error with the ivus is attributed to the reported event.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 a lutonix drug coated balloon (dcb) dilatation catheter was used to treat the right femoral artery.It was further reported that approximately 9-month post procedure, reocclusion was identified in the target lesion and a revascularization was performed successfully.The investigator determined that the event was possibly related to the procedure, but not related to the study device.

• 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: 8795743
• Report Number: 3006513822-2019-00099
• Device Sequence Number: 1977555
• Product Code: ONU
• UDI-Device Identifier: 00801741122903
• UDI-Public: (01)00801741122903
• 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): 07/16/2019

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: 08/29/2020
• Device Model Number: 9004
• Device Catalogue Number: LX357561205F
• Device Lot Number: GFBV4108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/16/2019
• 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: 63 YR
• Patient Weight: 65