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 08/02/2018

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 5 additional reocclusion complaints were 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.The investigator assessed that the event was probably related to the study device.Based on the instructions for use (ifu), the occurrence of reocclusion is an inherent risk of any pta procedure, and has been reported in clinical trials of drug coated balloons.If additional information becomes known to the manufacturer, a supplemental report will be provided 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 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 in the distal right superficial femoral artery (sfa).Approximately 23 months after the index procedure, the patient¿s right distal sfa vasculature was reported to have no flow during the patient's 2 year follow-up and complaints of progressive claudication.No additional intervention has been performed at this time.No additional surgical intervention has been performed at this time, but the hcp did recommended continued anti-platelet therapy with follow up visits.The investigator assessed that the event was probably related to the study device.The sample was discarded by the user facility and is not available for 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: john risse ; 9409 science center dr; new hope, MN 55428 ; 7634632917
• MDR Report Key: 7902745
• MDR Text Key: 121495451
• Report Number: 3006513822-2018-00204
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088599
• UDI-Public: (01)00801741088599
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2018

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: 10/31/2017
• Device Model Number: 9004
• Device Catalogue Number: 9050613500060
• Device Lot Number: GFZK0130
• 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: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2015
• 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: 65 YR
• Patient Weight: 72