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	Intimal Dissection (1333)
Date of Event	09/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates 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 hcp performed imaging after "predilataion" and the vessel was clear of obstruction.The hcp used two lutonix dcbs to treat the similar location successfully.Reportedly, the hcp performed imaging, after treatment with the lutonix dcbs, and the vessel was obstructed with a grade c dissection.The hcp used a stent to correct the obstructed flow in the treated vessel.Based on the instructions for use (ifu), the occurrence of dissection is an inherent risk of any pta procedure.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 the (b)(6) clinical registry, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used as the primary treatment for an occluded target lesion in the superficial femoral artery (sfa).The health care professional (hcp) predilated the target lesion with an ultrascore balloon successfully.The hcp performed imaging and the vessel was clear of all obstructions.The hcp used two lutonix dcb's to treat the target lesion location successfully.Reportedly, the hcp performed imaging after dcb treatment and the vessel was obstructed due to a grade c dissection.The hcp used a stent to correct the obstructed flow in the treated vessel.The lutonix dcbs were discarded by the user facility and are not available for evaluation.Although requested, additional information was unable to be obtained.No adverse patient outcomes were reported.This is one of two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2018-00264.

• 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: 8069811
• Report Number: 3006513822-2018-00265
• Device Sequence Number: 16714284
• Product Code: ONU
• UDI-Device Identifier: 00801741123207
• UDI-Public: (01)00801741123207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 11/14/2018

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: 01/15/2021
• Device Model Number: 9004
• Device Catalogue Number: LX351305605F
• Device Lot Number: GFCN1533
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/14/2018
• 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 Weight: 66