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

Model Number	9004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Rash (2033)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.Three of the four devices used on this patient came from the same lot.Therefore, a lot history review revealed 2 additional hypersensitivity complaints for 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 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 or Problem 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, 3006513822-2018-00036, and 3006513822-2018-00037.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 7309318
• Report Number: 3006513822-2018-00035
• Device Sequence Number: 1355177
• Product Code: ONU
• UDI-Device Identifier: 00801741088759
• UDI-Public: (01)00801741088759
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513051505F
• Device Lot Number: GFBV1957
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 83 YR
• Patient Weight: 68