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 Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Rash (2033)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates 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), the occurrence of an allergic reaction, hypertension, and a rash are inherent risks of a pta procedure with a paclitaxel drug coated balloon.Furthermore, the patient was reportedly treated with four lutonix dcb's, which exceeded the maximum amount of paclitaxel that was clinically evaluated for safety and effectiveness in a human patient.The hcp administered hydrochloride and epinephrine.The patient was asymptomatic at the conclusion of the procedure.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 after treatment with four lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters reportedly the patient experienced hypertension, and an itchy red rash.The health care professional (hcp) administered hydrochloride and epinephrine.At the conclusion of the procedure, the patient was asymptomatic.No further adverse patient outcomes were reported.The lutonix dcb's were discarded by the user facility and are not available for evaluation.This is one of four products involved with the reported event and the associated manufacturer¿s report numbers are 3006513822-2018-00034, 3006513822-2018-00035, and 3006513822-2018-00036.

• 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: 7309468
• MDR Text Key: 101378558
• Report Number: 3006513822-2018-00037
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741123306
• UDI-Public: (01)00801741123306
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513061505F
• Device Lot Number: GFBW2259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• 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: 83 YR
• Patient Weight: 68