MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number	9004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample disposition is unknown at this time; therefore, evaluation was unable to be performed.The product identifiers were obtained; therefore, a device history record (dhr) was reviewed for this device.A review of the manufacturing record show the lot was manufactured to specification.Multiple attempts have been made to obtain sample disposition, patient demographics, and event details, but the information is unavailable at the time of this report.Conclusion: the actual sample was not received for evaluation.If additional information is made available or the sample is returned for evaluation, a supplement report will be submitted with 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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured when treating the external iliac artery.The health care professional (hcp) performed an atherectomy of the external iliac artery prior to treating the target lesion with the lutonix dcb.The hcp used another lutonix dcb to complete the patient's procedure.The disposition of the sample is unknown at this time.Multiple requests for additional information have been made, but additional information is unavailable.No 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): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 5348335
• Report Number: 3006513822-2015-00072
• Device Sequence Number: 18934058
• Product Code: ONU
• UDI-Device Identifier: 00801741105012
• UDI-Public: (01)00801741105012(17)170519(10)LUZE0012A
• 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,health profession
• Initial Reporter Occupation: Physician
• Report Date (Section B): 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2017
• Device Model Number: 9004
• Device Catalogue Number: BSCLX351305150
• Device Lot Number: LUZE0012
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1