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

Catalog Number	NCEUP4508X
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	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The balloon couldn¿t track over the wire.After excessive force was applied, the distal assembly of the nc euphora separated.It was stated that the distal assembly completely detached from the nc euphora device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the guidewire was not returned for analysis.There was a detachment at the exchange joint.No kinks were evident on the device.There was approx.2.5cm of the support wire exposed.The material was jagged and uneven on both sides of the detachment site.A 0.014 inch guidewire was backloaded through the distal tip and advanced proximally through the detachment site at the exchange joint with no issue noted.It was not possible to inflate the balloon due to the condition of the returned device.There was no damage evident to the distal tip.There was no damage evident to the proximal balloon bond.The inner lumen was verified with a 0.015inch mandrel.There was no other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 4.50 x 8 mm nc euphora balloon and a cougar ls guidewire were used to perform multiple bifurcation stenting techniques in an explanted porcine heart.The guidewire was flushed and examined before use with no issues.There were no issues noted when loading the balloon onto the guidewire.It was reported that the nc euphora balloon froze on the cougar wire and after excessive force applied the distal assembly separated.It was stated that the distal assembly completely detached from the device.The balloon, wire and distal assembly were all removed.The procedure was completed using new devices.

• 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: 9335096
• Report Number: 9612164-2019-04784
• Device Sequence Number: 11225030
• Product Code: LOX
• UDI-Device Identifier: 00643169396180
• UDI-Public: 00643169396180
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 01/02/2021
• Device Catalogue Number: NCEUP4508X
• Device Lot Number: 216861320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1