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

Catalog Number	NCEUP4508X
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician was using an nc euphora balloon to treat a non- tortuous lesion in the lad.Ivus showed fibrotic/calcific plaque, 80% stenosis in the proximal lad.No damage was noted to packaging and the device had no issues reported when inspected upon removal from hoop.No resistance was encountered when advancing the device and no anatomical abnormalities were reported.The device did not pass through a previously deployed stent.The device was successfully inflated within rbp.It was reported that difficulty was encountered in removing the nc euphora balloon (nceup4012x).During retraction, the balloon wrapped around the wire.The physician then attempted to use another nc euphora (nceup4508x) balloon.No damage was noted to packaging and the device had no issues reported when inspected upon removal from hoop.No resistance was encountered when advancing the device.The device did not pass through a previously deployed stent but after it was deflated the balloon also wrapped around the wire.No injury to the patient was reported.
Additional Manufacturer Narrative
Evaluation summary: the balloon returned slightly inflated, with residue present in the inflation lumen and balloon.The hypotube was kinked in numerous places.There was deformation to the distal tip.The guidewire entry port was damaged.The distal shaft was kinked 20.8cm distal to the guidewire entry port.The patency of the device was verified when a 0.015¿ mandrel was loaded through the inner lumen with no resistance.(b)(4).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6157541
• Report Number: 9612164-2016-01242
• Device Sequence Number: 19015373
• Product Code: LOX
• UDI-Device Identifier: 00643169396180
• UDI-Public: 00643169396180
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2016

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: 07/08/2017
• Device Catalogue Number: NCEUP4508X
• Device Lot Number: 209825049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2016
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: Not provided; 12/16/2016
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 01/04/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 116