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

Model Number	9004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample has not been returned for evaluation.A lot history review revealed this is the only complaint for this lot.A review of the manufacturing record show the lot was manufactured to specification.Patient and procedural details have been requested but were not available at the time of this report.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.If additional information is obtained or the sample is returned, a supplement report will be submitted with all relevant information.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly had a material rupture.The health care professional (hcp) reportedly advanced the dcb to the target lesion.Upon inflation of the lutonix dcb at the target lesion, the hcp reportedly realized blood was accumulating inside the indeflator.Based on this observation, the hcp believed that the balloon had allegedly "ripped".The hcp removed the balloon successfully from the patient and used another lutonix dcb of the same size to effectively complete the procedure.The lutonix dcb was requested to be returned.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: 5525894
• Report Number: 3006513822-2016-00071
• Device Sequence Number: 1037569
• Product Code: ONU
• UDI-Device Identifier: 00801741098499
• UDI-Public: (01)00801741098499(17)171123(10)GFAN0170
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2017
• Device Model Number: 9004
• Device Catalogue Number: BSCLX35130660
• Device Lot Number: GFAN0170
• 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: 03/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1