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

Catalog Number	NCEUP3020X
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	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician was attempting to use a nc euphora to treat a non-calcified and non-tortuous proximal lad lesion.No issues were noted with the device packaging.The device was removed from the hoop/ tray with no issues.The device was inspected with no issues noted.Negative prep was performed successfully.The lesion was not pre-dilated.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered during advancement or excessive force required.It was reported that the physician felt the device snap when advancing the nc euphora through the guide catheter.The detachment occurred at the femoral marker and it broke in two parts.The tip of the device did not exit the guide catheter.The guide catheter, wire and balloon shaft were removed from the patient as one unit.Everything came out of the body.Procedure was completed with another device.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary: the hypotube had detached 42.2cm distal to the strain relief.Both ends of the hypotube were oval and uneven at the break site.The hypotube was kinked 14.0cm proximal and 12.5cm distal to the break site.The distal tip was damaged.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: 6577671
• Report Number: 9612164-2017-00607
• Device Sequence Number: 13486153
• Product Code: LOX
• UDI-Device Identifier: 00643169395848
• UDI-Public: 00643169395848
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/15/2017

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: 03/22/2019
• Device Catalogue Number: NCEUP3020X
• Device Lot Number: 212999800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 07/15/2017; 07/15/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 08/14/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 74