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	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.The lot history review could not be conducted because the lot number, although requested, was not available from the user facility.The dhr review also was not conducted because the facility did not provide the lot number.Conclusion: the actual sample was not returned for evaluation.The dhr review was not conducted because the facility did not provide the lot number.The investigator assessed the event was not related to the lutonix device or procedure.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.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.
Event or Problem Description
It was reported through a post market clinical study that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left superficial femoral artery (sfa).Approximately 10 months after the index procedure, the patient¿s left sfa was reportedly reoccluded.A revascularization involving placement of a bare metal stent was performed and the health care professional (hcp) deemed it was successful.The investigator assessed that the event was not related to the study devices or procedure.The samples were discarded by the user facility and are not available for evaluation.No adverse patient effects were reported.This is one of two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2019-00029.

• 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: 8380139
• Report Number: 3006513822-2019-00028
• Device Sequence Number: 13539284
• Product Code: ONU
• UDI-Device Identifier: 00801741123221
• UDI-Public: (01)00801741123221
• 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): 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513051005F
• Device Lot Number: GFBV1127
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/28/2019
• 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: 76 YR
• Patient Weight: 52