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

Catalog Number	NCEUP2515X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.There was a detachment on the hypotube approx.42.5cm distal to the strain relief.Kinks were evident on the hypotube, including kinks 2.2cm proximal to the detachment site and 2.4cm distal to the detachment site.The hypotube material was oval and jagged on both sides of the detachment site.Kinks were visible on the distal shaft distal to the guidewire entry port bond.
Event or Problem Description
It was reported that the physician intended to use a nc euphora balloon catheter to treat a lesion located in the proximal circumflex artery which was reported to have no calcification but mildly tortuous with 80% stenosis.No damage was noted to packaging and no issues were encountered when removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues.The lesion was pre-dilated.It was reported the shaft of the balloon broke during insertion into the guide catheter.The device did not pass through a previously deployed stent but resistance was encountered when advancing the device but no excessive force was used.
Additional Manufacturer Narrative
It was reported the mid shaft of the balloon broke during advancement of the device.The device was not inflated.The detached portion was removed from the patient by pulling the whole device out.There was no extra tension.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.
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: 6525226
• Report Number: 9612164-2017-00517
• Device Sequence Number: 13674284
• Product Code: LOX
• UDI-Device Identifier: 00643169396159
• UDI-Public: 00643169396159
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/11/2017

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: 04/15/2018
• Device Catalogue Number: NCEUP2515X
• Device Lot Number: 211125308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: Not provided; 05/11/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 06/09/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR