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 Codes	Skin Discoloration (2074); Thrombosis (2100)
Date of Event	02/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample was not returned to 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) 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 related to the device or procedure.Based on the instructions for use (ifu), the occurrence of a thrombosis is an inherent risk of any pta procedure.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
Reportedly after the treatment of the target lesion with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, a flow limiting thrombus occurred.The health care professional (hcp) used a 4mm angioplasty balloon to predilate the distal superficial femoral artery (sfa) and the popliteal artery.The lutonix dcb was used to treat the target lesion and after treatment, a thrombus occurred.The timeframe from the thrombus occurrence to thrombectomy treatment by the hcp is unknown.Reportedly, the patient's skin was discolored.The lutonix dcb was requested to be returned for evaluation, but is unavailable.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: 6434066
• Report Number: 3006513822-2017-00052
• Device Sequence Number: 13528714
• Product Code: ONU
• UDI-Device Identifier: 00801741088636
• UDI-Public: (01)00801741088636(17)170609(10)GFAS0724
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2017

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: 06/09/2017
• Device Model Number: 9004
• Device Catalogue Number: 9020413500080
• Device Lot Number: GFAS0724
• 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: 03/24/2017
• 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: 82 YR