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

Catalog Number	EUP3010X
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The device returned with numerous kinks evident along the hypotube.The stylette returned loaded in the inner lumen.The stylette was partially removed from the device.Residue was visible on the surface of the stylette.The distal shaft was slightly stretched and kinked approx.7cm distal to the guidewire entry port.There was no stretching of the distal tip.
Event or Problem Description
It was reported that the physician was attempting to use two euphora rx balloons.No damage was noted to the device packaging and no issues were noted when removing the devices from the hoop/tray.The devices were inspected with no issues noted.Negative prep was performed with no issues noted.It was reported that issues were encountered when trying to remove the stylet on both devices.The devices were flushed in the hoop/placed in a bowl of saline to activate the hydrophilic coating.The physician did say he had difficulty removing the stylet but was able to do so and the stylet issue had no impact on the patient as he was able to dilate.The physician wanted to use the 2nd balloon to dilate the lesion again but the stylet could not be removed.After initial resistance was encountered when removing the sheath/ stylette the physician pulled harder and ripped his glove, this occurred with the 2nd balloon.
Additional Manufacturer Narrative
Recall ticked in error.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: 6787770
• Report Number: 9612164-2017-01099
• Device Sequence Number: 132594
• Product Code: LOX
• UDI-Device Identifier: 00643169560130
• UDI-Public: 00643169560130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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: 10/14/2018
• Device Catalogue Number: EUP3010X
• Device Lot Number: 212118703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1