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	Claudication (2550)
Date of Event	04/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned to the user facility; therefore, evaluations of the actual samples are unable to be performed.A lot history review revealed this is the only claudication complaint associated with this lot.A review of the device history record (dhr) shows the lot was manufactured to specification.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The investigator assessed the event was possibly related to the study device and/or the study procedure.Based on the instructions for use (ifu), the occurrence of a claudication 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 will all relevant information.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that 30 days after treatment with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, the patient allegedly experienced ongoing leg pain.The patient reports the leg pain began the day after the study procedure.Per the investigator, the etiology is unknown, but may possibly be related to lutonix dcb and/or the study procedure.The investigator performed a differential diagnoses which includes possible causes from plavix, paclitaxel, polymyalgia rheumatica, or other systemic processes, because the relationship to the device or procedure cannot be ruled out.The lutonix dcb was discarded by the user facility and is not available for further evaluation.No further adverse patient effects were reported.

• 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: 5706026
• Report Number: 3006513822-2016-00128
• Device Sequence Number: 13531678
• Product Code: ONU
• UDI-Device Identifier: 00801741088636
• UDI-Public: (01)00801741088636(17)170116(10)GFZA1525
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2016

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: 01/16/2017
• Device Model Number: 9004
• Device Catalogue Number: LX35130580
• Device Lot Number: GFZA1525
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR