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

Model Number	EUP2015X
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
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
A euphora balloon catheter was attempted to be used to treat a moderately tortuous, moderately calcified lesion with 95% stenosis in the proximal-mid lad.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues.The device was not kinked and re-straightened during use.Two balloons were inside the guide catheter, the euphora balloon and an unknown brand balloon.It was reported that the devices became entangled and could not be advanced.When an attempt was made to remove the balloon, a detachment occurred.The euphora balloon separated from the delivery system.All components stayed in the guide catheter and were removed together when the guide was removed.No components remain in the patient.It is also reported that the catheter became stretched.No other devices were tried after they removed the guide.No patient injury is reported.
Additional Manufacturer Narrative
The guide catheter was non-medtronic.A second euphora balloon was in the guide catheter and was entangled with the euphora that had the detachment.The second euphora was not damaged.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: deformation was evident to the hypotube from 2cm to 54cm distal to the strain relief.There was a detachment on the transitional tubing 3cm distal to the proximal end of the transition tubing.The support wire was exposed distal to the detachment site.The transitional material was oval and jagged on both sides of the detachment site.The detached portion of the device was loaded on to a guidewire.The distal shaft was entangled around the guidewire.The guidewire lumen appeared deformed and bunched, the inflation lumen appeared wrinkled.A portion of the inflation lumen appeared to be torn.Deformation was evident to the transitional tubing.No deformation was evident to the guidewire.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 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: 7889664
• Report Number: 9612164-2018-02446
• Device Sequence Number: 19514488
• Product Code: LOX
• UDI-Device Identifier: 00643169559899
• UDI-Public: 00643169559899
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• 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,Followup
• Report Date (Section B): 01/28/2019

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: 04/18/2019
• Device Model Number: EUP2015X
• Device Lot Number: 213151447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 09/25/2018; 11/26/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/15/2018; 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 80