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

Catalog Number	NCEUP2506X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2017
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
It was reported that the physician intended to use a nc euphora ptca balloon catheter to treat a non-tortuous and non-calcified lesion located in the distal right coronary artery.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.Negative prep was performed with no issues noted.The device was inspected with no issues identified.The lesion was pre-dilated.There was no resistance encountered when advancing the device.Excessive force was not used during delivery.It was reported that the balloon was expired (approx 31 days past its expiration date).In a stemi case the physician requested a euphora balloon 2.5 x 6 rx and the staff retrieved the unit from the inventory area.Before the package was opened, it was then noted by the staff the unit had an expiration date of 9-1-2017 and the physician was informed.The physician requested to open the package and use the balloon with full knowledge of the expiration date.No intervention was used.Patient status post-procedure is alive with no injury.Patient is stable and was discharged from hospital.

• 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: 6982786
• Report Number: 9612164-2017-01508
• Device Sequence Number: 488330
• Product Code: LOX
• UDI-Device Identifier: 00643169395954
• UDI-Public: 00643169395954
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: 09/01/2017
• Device Catalogue Number: NCEUP2506X
• Device Lot Number: 210083690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1