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

Model Number	NCEUP4512X
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	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: two images were provided.The first image shows a detached hypotube.The second image shows an nc euphora balloon with the balloon folds intact.The device was being used to treat a lesion in the mid lad.It was stated that there was 70% stenosis at the proximal lad.The nc euphora balloon catheter was inspected before use with no issues noted.Detachment occurred during advancement of the nc euphora balloon catheter.The balloon catheter was not inflated.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.
Event or Problem Description
During a procedure an attempt was made to use a nc euphoria ptca balloon catheter to treat a lesion.It was reported that the balloon catheter snapped in half as it was going into the patients body.The device was removed without complications.No patient injury was reported.

• 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: 9715878
• Report Number: 9612164-2020-00733
• Device Sequence Number: 11545472
• Product Code: LOX
• UDI-Device Identifier: 00643169396173
• UDI-Public: 00643169396173
• 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: User Facility
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2020

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: 11/07/2021
• Device Model Number: NCEUP4512X
• Device Catalogue Number: NCEUP4512X
• Device Lot Number: 218875283
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/14/2020; 04/03/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/04/2020; 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 109