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

Model Number	9004
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: 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 this lot.The 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 has been discarded by the user facility and will not be returned for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.If additional information is obtained, 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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly would not inflate at the target lesion.The health care professional (hcp) removed the lutonix dcb from the patient and attempted to inflate it.As the hcp tried to inflate the balloon outside of the patient, reportedly there was a hole in the balloon because it would not fill with fluid.The hcp used another lutonix dcb of the same size to complete the procedure.The lutonix dcb was discarded by the user facility.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: 6538006
• Report Number: 3006513822-2017-00073
• Device Sequence Number: 11063249
• Product Code: ONU
• UDI-Device Identifier: 00801741105029
• UDI-Public: (01)00801741105029(17)181013(10)GFAY0723
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/02/2017

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: 10/13/2018
• Device Model Number: 9004
• Device Catalogue Number: BSCLX351306150
• Device Lot Number: GFAY0723
• 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: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR