MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 018 DRUG COATED BALLOON PTA CATHETER

Model Number	9014
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed this is the only complaint associated for this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual sample was not returned for evaluation.The dhr review concluded the balloon was manufactured to specification upon release of the sample.However, a review of the received fluoroscopic image provided by the hcp, allegedly represents a non uniform, twisted, partially inflated lutonix dcb in the image.Based on the information provided, a definitive root cause could not be established.It is unknown if the patient and/or procedural issues contributed to the reported event.If additional information becomes known to the manufacturer, a supplemental report will be provided will all relevant information.
Event or Problem Description
It was reported a lutonix 018 percutaneous transluminal drug coated balloon (dcb) dilatation catheter was allegedly twisted at the distal end while treating the target lesion in the distal superficial femoral artery (sfa) and proximal popliteal artery.The health care professional (hcp) used a contralateral approach to gain patient access with a 6 french destination introducer sheath over an 014 phoenix guidewire.The hcp prepared the target lesion with atherectomy.Reportedly, the hcp advanced the catheter to the target lesion without twisting the catheter.Allegedly, after inflation of the lutonix dcb, it was twisted approximately 10 cm from the distal end of the balloon at 8 atmospheres (atms).The hcp moved the balloon after the 2 min inflation period, and the twisted area did not change.The hcp reportedly removed the twisted lutonix dcb and used another device to complete the procedure.The lutonix dcb was discarded by the user facility and is not available for return.No adverse patient outcomes were reported.

• Brand Name: LUTONIX 018 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: 8615448
• Report Number: 3006513822-2019-00080
• Device Sequence Number: 2180164
• Product Code: ONU
• UDI-Device Identifier: 00801741177637
• UDI-Public: (01)00801741177637
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/16/2019

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: 12/13/2020
• Device Model Number: 9014
• Device Catalogue Number: LX1813052205F
• Device Lot Number: GFDN3412
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 103