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	02/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was discarded at the user facility; therefore, evaluation was unable to be performed.A lot history review revealed this is the only complaint associated with dissection for this lot.The product identifiers were obtained; therefore, a device history record (dhr) was reviewed for this device.A review of the manufacturing record show the lot was manufactured to specification.Conclusion: the actual sample will not be 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 a dissection is an inherent risk of any pta procedure.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 grade d dissection was allegedly present after treatment with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter.The health care professional (hcp) gained access to treat the mildly calcified distal superficial femoral artery (sfa).The hcp predilated the target lesion with a boston scientific sterling pta balloon.The hcp then treated the target lesion with the lutonix dcb for 185 seconds at nine atmospheres of pressure, which resulted in a grade d dissection of the lesion.The hcp used an intact vascular tack endovascular system to successfully treated the grade d dissection.The lutonix dcb was discarded by the user facility and is not available for return.No adverse patient effects were reported.

• 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: 5504307
• Report Number: 3006513822-2016-00016
• Device Sequence Number: 11036951
• Product Code: ONU
• UDI-Device Identifier: 00801741088643
• UDI-Public: (01)00801741088643(17)170116(10)GFZA1523
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/17/2016

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: 01/16/2017
• Device Model Number: 9004
• Device Catalogue Number: LX35130680
• Device Lot Number: GFZA1523
• 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: 03/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTACT VASCULAR TACK SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 115