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	10/16/2017
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.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 was not received for evaluation.There was nothing found to indicate there was a manufacturing related cause for this event.A definitive root cause could not be determined based on the information provided.It is unknown if the patient and/or procedural issues contributed to the reported event.If additional information is received, 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 ruptured at 10 atmospheres (atms) on the first inflation while treating the target lesion.The health care professional (hcp) predilated the target lesion prior to treating the location with the lutonix dcb.The hcp used an additional device to complete the procedure.Although requested several times, additional information regarding patient demographics and event details were unavailable.The lutonix dcb was requested to be returned for evaluation, but the user facility has discarded the sample.No adverse patient outcomes 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: 7031116
• Report Number: 3006513822-2017-00288
• Device Sequence Number: 1005013
• Product Code: ONU
• UDI-Device Identifier: 00801741123290
• UDI-Public: (01)00801741123290
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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: 02/28/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513061205F
• Device Lot Number: GFBQ0443
• 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: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1