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	Gangrene (1873)
Date of Event	04/28/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample(s) were 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 similar complaint associated with this lot.A review of the device history record (dhr) shows the lot was manufactured to specification.Conclusion: the actual samples were 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, drug or procedure.Based on the patient's presenting medical condition prior to the angioplasty procedure, it is unlikely the lutonix dcb's caused or contributed to the events.If additional information becomes known to the manufacturer, a supplemental report will be provided will all relevant information.
Event or Problem Description
It was reported that prior to the index procedure, allegedly the patient had a purulent nail bed inflammation and periungual necrosis of the first toe left side at the time of enrollment and the index procedure.Treatment with antibiotics, tavanic, was started during the index procedure admission.The patient was then treated with three lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter.Reportedly, a few months later the patient's first toe left side of the target limb became inflamed from the pre-existing infected skin ulcer.The patient was hospitalized and reportedly an amputation was performed due to progressive gangrene of the left forefoot.The cec adjudicated the event as possibly related to the study device, drug or procedure.The sample was discarded by the user facility and not available for further evaluation.No adverse patient effects were reported.This is one of three products involved with the reported event and are associated manufacturers report numbers 3006513822-2016-00058 and 3006513822-2016-00059.

• 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: 5510641
• Report Number: 3006513822-2016-00057
• Device Sequence Number: 1162746
• Product Code: ONU
• UDI-Device Identifier: 00801741088353
• UDI-Public: (01)00801741088353(17)160530(10)GFYE1547
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P130024
• 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): 03/01/2016

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: 05/30/2016
• Device Model Number: 9004
• Device Catalogue Number: 9020410500080
• Device Lot Number: GFYE1547
• 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: 03/18/2016
• 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: Other
• Patient Age: 67 YR
• Patient Weight: 81