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

Catalog Number	NCEUP2512X
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	05/09/2019
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
An nc euphora was intended to be used during a procedure.No damage noted to packaging.No issues removing the device from the hoop.The device was inspected with no issue noted.Negative prep was performed with no issues.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It is reported that the balloon had just started to be inserted when the shaft broke/detached, during delivery through the vessel.The device was pulled out.No part of the device remained in the patient.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation summary: the device returned with a detachment on the hypotube at the radiopaque markerband, 52.6cm distal to the strain relief.A kink was evident on the hypotube distal to the detachment site.The hypotube material was oval and jagged on both sides of the detachment site.No other damage evident to the remainder of the device.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: 8602815
• Report Number: 9612164-2019-01685
• Device Sequence Number: 3019709
• Product Code: LOX
• UDI-Device Identifier: 00643169395930
• UDI-Public: 00643169395930
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/06/2019

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: 02/06/2021
• Device Catalogue Number: NCEUP2512X
• Device Lot Number: 217084147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1