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 08/15/2015

Event Type  Injury  

Manufacturer Narrative

The sample was discarded at the user facility: therefore, evaluation was unable to be performed.The product identifiers were obtained; therefore, a device history record (dhr) was reviewed for this device.A lot history review revealed this is the only complaint for this lot.A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The hcp treated the target lesion with the lutonix dcb successfully without device malfunction.The patient presented with lower leg swelling during follow up.Diagnostic ultrasound, performed during follow up, ruled out evidence of acute deep vein thrombosis of the target lesion, but could not exclude calf vein thrombosis.The patient was treated with an oral regiment of lasix and additional care instructions for the swollen limb.Based on the information obtained related to the event and the investigation, a definite root cause cannot be determined.Swelling is a known risk of any pta procedure.

Event Description

It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly caused lower extremity swelling in the patient, post lutonix dcb treatment.The health care professional (hcp) performed an atherectomy followed by predilation with a normal pta balloon of the patient's right superficial femoral artery (sfa).The hcp treated the target lesion with the lutonix dcb successfully without device malfunction.Approximately two weeks later, the patient presented to the hcp with lower leg swelling.The physician believes the swelling is possibly related to the procedure and products used, including the lutonix dcb.Approximately 2 months later, the patient still had pitting edema and was prescribed lasix 20mg/day for 3-5 days, elevate leg, low salt intake, and to wear a support stocking.A venous ultrasound was conducted and ruled out evidence of acute deep vein thrombosis but could not with certainty exclude isolated calf vein thrombosis.The sample was discarded at the user facility.No further adverse patient effects at this time.

• 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: 5236755
• MDR Text Key: 31623094
• Report Number: 3006513822-2015-00057
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088766
• UDI-Public: (01)00801741088766(17)170521(10)LUZE0018
• 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: 10/20/2015

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: 05/21/2017
• Device Model Number: 9004
• Device Catalogue Number: LX351306150
• Device Lot Number: LUZE0018
• 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: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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 Outcome(s): Hospitalization
• Patient Age: 65 YR