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	03/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination of the entire length of the catheter revealed no visually identifiable damage.Functional testing was performed revealing a longitudinal material rupture which was present through the majority of the balloon length.The edges of the longitudinal material rupture were not jagged.The balloon was unable to maintain negative pressure due to the longitudinal material rupture.The catheter shaft was not damaged.A lot history review revealed this is the only complaint associated with material rupture for this lot.A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution.Conclusion: returned product analysis confirmed a longitudinal material rupture which was present through the majority of the balloon length.The patient procedure involved an angiogram with balloon angioplasty or stent replacement.Field assurance made multiple attempts for more information including but not limited to the following information: predilation of the target lesion, morphology of vasculature regarding calcified/tortuous lesion(s), if negative pressure was applied, and/or patient procedure related to stent placement.The longitudinal balloon rupture may possibly be due to a lack of predilation of the atherosclerosis in the target lesion.There was nothing found to indicate there was a manufacturing related cause for this event.It is unknown if 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.The health care professional (hcp) inflated the balloon to nominal pressure, while treating atherosclerosis of the native artery in the lower extremity.The hcp removed the lutonix dcb and used another balloon to complete the patient's procedure.Although requested, additional event information and patient demographics were unavailable.The lutonix dcb was returned for evaluation.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: 7473371
• Report Number: 3006513822-2018-00097
• Device Sequence Number: 13481205
• Product Code: ONU
• UDI-Device Identifier: 00801741123313
• UDI-Public: (01)00801741123313
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: 01/05/2019
• Device Model Number: 9004
• Device Catalogue Number: LX351307405F
• Device Lot Number: GFBN0488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1