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

Catalog Number	EUP2515X
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	04/28/2017
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 damage to the tip.Residue was present at the distal tip.The distal tip was stretched and necked onto the stylette.Kinks were evident on the distal shaft at 10.5cm, 11.2cm and 12.3cm distal to the distal end of the guide wire entry bond.The balloon bond is stretched.The balloon was inflated to rbp and the balloon burst immediately after inflation.
Event or Problem Description
It was reported that the physician was attempting to use a euphora rx balloon.No damage was noted to the device packaging and the device was inspected with no issues noted.No difficulty was experienced when removing the device from the hoop.The device was flushed in the hoop and placed in a bowl of saline to activate the hydrophilic coating.It was reported that the stylette could not be removed and it was reported that it felt like it was glued in place.The physician was able to finally remove the protective sheath using force, but it came a part creating a sharp edge that tore his glove.The 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: 6745784
• Report Number: 9612164-2017-00953
• Device Sequence Number: 10983385
• Product Code: LOX
• UDI-Device Identifier: 00643169560024
• UDI-Public: 00643169560024
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 03/23/2019
• Device Catalogue Number: EUP2515X
• Device Lot Number: 213012238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• 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: 09/29/2017
• 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