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 Code	Swelling (2091)
Date of Event	07/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample(s) were not returned to the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed there are no similar complaints associated with this lot.A review of the device history record (dhr) shows 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), an allergic reaction is a potential inherent risk of any pta procedure involving a drug coated balloon.If additional information becomes known to the manufacturer, a supplemental report will be provided will 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 a few days after the index procedure with two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, the patient allegedly developed lower limb swelling after taking a prescribed oral medication.The prescribed medication was (b)(6).The patient called the doctor's office on (b)(6) and stated, "shortly after taking his (b)(6), a day after the index procedure, foot swelling occurred with a rash on both feet." the physician discussed holding the (b)(6) at the time of the call, but to continue all other prescribed medications.The patient feels good otherwise and no other symptoms have appeared.This is one of two products involved with the reported event and the associated manufacturers report numbers are 3006513822-2016-00156.

• 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: 5855179
• Report Number: 3006513822-2016-00157
• Device Sequence Number: 11073300
• Product Code: ONU
• UDI-Device Identifier: 00801741088551
• UDI-Public: (01)00801741088551(17)170626(10)GFZG0276
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2016

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: 06/26/2017
• Device Model Number: 9004
• Device Catalogue Number: LX35130540
• Device Lot Number: GFZG0276
• 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: 08/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 59