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

Model Number 9004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

Analysis: the sample(s) were not returned to the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed there are no similar complaints 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.Based on the instructions for use (ifu), an allergic reaction is a potential inherent risk of any pta procedure involving a drug coated balloon.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 Description

It was reported a few days after the index procedure with two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, the patient allegedly developed lower limb swelling after taking a prescribed oral medication.The prescribed medication was plavix.The patient called the doctor's office on (b)(6) and stated, "shortly after taking his plavix, a day after the index procedure, foot swelling occurred with a rash on both feet." the physician discussed holding the plavix at the time of the call, but to continue all other prescribed medications.The patient feels good otherwise and no other symptoms have appeared.This is one of two products involved with the reported event and the associated manufacturers report numbers are 3006513822-2016-00157.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer (Section G): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634458639
• MDR Report Key: 5855146
• MDR Text Key: 51443473
• Report Number: 3006513822-2016-00156
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088759
• UDI-Public: (01)00801741088759(17)170519(10)LUZE0012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2017
• Device Model Number: 9004
• Device Catalogue Number: LX351305150
• Device Lot Number: LUZE0012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 59