MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number 9004

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

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed 1 additional reocclusion complaint was associated with this lot.A review of the device history record (dhr) indicates 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.Reportedly, the patient had a reintervention involving the target lesion and additional vessels on (b)(6) 2016, but it is unknown what treatment was performed.A target lesion reintervention was performed on (b)(6) 2017, reportedly after the patient experienced lifestyle limiting claudication.The investigator assessed that the lifestyle limiting claudication was possibly related to the study device used during the index procedure as well as the index procedure.Based on the instructions for use (ifu), the occurrence of reocclusion and claudication are inherent risks of any pta procedure.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.

Event Description

It was reported through a clinical registry that during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the right distal superficial femoral artery (sfa).Approximately 6 months after the index procedure, the patient allegedly experienced lifestyle limiting claudication at the target limb due to the reocclusion of the target lesion and vessel.Reportedly, the patient had a reintervention involving the target lesion and additional vessels on (b)(6) 2016, but it is unknown what treatment was performed.A target lesion reintervention was performed on (b)(6) 2017, reportedly after the patient experienced lifestyle limiting claudication.The investigator assessed that the lifestyle limiting claudication was possibly related to the study device used during the index procedure as well as the index procedure.The sample was discarded by the user facility and is not available for further evaluation.No adverse patient effects were reported.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634458639
• MDR Report Key: 8196011
• MDR Text Key: 131397427
• Report Number: 3006513822-2018-00295
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088605
• UDI-Public: (01)00801741088605
• 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: 12/26/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2016
• Device Model Number: 9004
• Device Catalogue Number: LX35130660
• Device Lot Number: GFYJ3014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2014
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 74