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

Catalog Number	EUP2012X
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	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The stylette was present in the tip of the returned device.The stylette was stuck in the device.There was no residue visible on the stylette.The distal tip is stretched.Balloon bond is stretched.Numerous kinks were evident on hypotube.The balloon was inflated within specification.The device failed to deflate.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was intending on using a euphora rx balloon in the patient.No damage was noted to the packaging nor were there any issues noted when removing the device form the hoop/tray.The device was inspected with no issues and negative prep was not performed.The device was not flushed in the hoop.The device was not placed in a bowl of saline to activate the hydrophilic coating.The package was opened by the nurse and removed by the tech.The tech then attempted to remove the stylet to prep the balloon.It is reported that it tore both the techs gloves and physicians gloves trying to get the stylet out.Device was not used in the patient.
Additional Manufacturer Narrative
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: 6745549
• Report Number: 9612164-2017-00950
• Device Sequence Number: 881937
• Product Code: LOX
• UDI-Device Identifier: 00643169559882
• UDI-Public: 00643169559882
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/20/2017

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: 01/16/2019
• Device Catalogue Number: EUP2012X
• Device Lot Number: 212613000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-3136-2017
• Patient Sequence Number: 1