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	Intimal Dissection (1333)
Date of Event	08/22/2017
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.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 dissection reocclusion is an inherent risk of any pta procedure.Although requested, the patient weight was unavailable.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 that a vessel dissection was allegedly present after the right superficial femoral artery(sfa) was treated with three lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters.The health care professional (hcp) performed an atherectomy, with a jetstream, on a third of the patient's highly calcified target lesion in the right sfa.The atherectomy was not performing to the physician satisfaction and decided to discontinue the atherectomy.The hcp elected to treat the highly calcified lesion with the lutonix dcb without additional lesion preparation.Allegedly, after lutonix dcb treatment, a dissection was present.The hcp placed an innova stent.The lutonix dcb's were discarded by the user facility and are not available for return.No adverse patient outcomes were reported.This is one of three products involved with the reported event and the associated manufacturer¿s report numbers are 3006513822-2017-00193 and 3006513822-2017-00194.

• 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: 6957747
• Report Number: 3006513822-2017-00195
• Device Sequence Number: 10985732
• Product Code: ONU
• UDI-Device Identifier: 00801741098475
• UDI-Public: (01)00801741098475
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2017

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: 02/21/2020
• Device Model Number: 9004
• Device Catalogue Number: BSCLX351306100
• Device Lot Number: GFBR0172
• 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: 10/18/2017
• 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: Required Intervention
• Patient Age: 68 YR