MAUDE Adverse Event Report: MEDTRONIC MEXICO NC EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number	NCEUP4015X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was intended to use a nc euphora balloon dilatation catheter to treat a moderately tortuous and calcified lesion located in the mid right coronary artery exhibiting 90% stenosis.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected and prepped with no issues noted.The lesion was pre-dilated.The device did pass through a previously-deployed stent.Resistance was encountered when advancing the device however excessive force was not used during delivery.It was reported that the first post- dilation was successful performed.The nc euphora never left the guide it was reported that when the physician was advancing the device to perform the second post-dilation, two wires crossed in the guide, the nc euphora catheter shaft kinked and broke in half while in the guide catheter, outside of patient.All components were successfully removed from the guide catheter.It was also reported that the device was not kinked and re-straightened during use and the detached portion of the device does not remain in the patient.No patient injury reported.
Additional Manufacturer Narrative
Additional information: post dilatation was successful with a second nceup4015x only after the second wire was removed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NC EUPHORA RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 6957315
• Report Number: 9612164-2017-01475
• Device Sequence Number: 1111728
• Product Code: LOX
• UDI-Device Identifier: 00643169396210
• UDI-Public: 00643169396210
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• 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,Followup
• Report Date (Section B): 12/08/2017

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: 10/22/2017
• Device Catalogue Number: NCEUP4015X
• Device Lot Number: 210325414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 98