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	Thrombosis (2100)
Date of Event	06/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned by the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed their are no similar complaints associated with this lot.Conclusion: the actual sample was not received for evaluation.Based on the instructions for use (ifu), the occurrence of a thrombosis is an inherent risk of any pta procedure.Upon completion of the investigation, a supplement report will be submitted 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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, allegedly a thrombosis formed in the fistula.The health care professional (hcp) successfully predilated the target lesion.The hcp then treated the target lesion with a lutonix dcb for approximately 1.5 minutes.Reportedly after treatment, diagnostic imaging revealed a complete thrombosis of the fistula.The hcp resolved the thrombosis with lysis and placed a stent.The lutonix dcb was discarded by the user facility and will not be available for further evaluation.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: 5827080
• Report Number: 3006513822-2016-00148
• Device Sequence Number: 13539830
• Product Code: ONU
• UDI-Device Identifier: 00801741088360
• UDI-Public: (01)00801741088360(17)160630(10)GFYE3706C
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/29/2016

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: 06/30/2016
• Device Model Number: 9004
• Device Catalogue Number: 9040410600080
• Device Lot Number: GFYE3706
• 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: 07/27/2016
• 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