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

Catalog Number	NCEUP4020X
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	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary the device returned with a detachment on the hypotube 52.2cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.The device returned with blood visible in the balloon and deformation was visible to the distal tip which appeared stubbed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use one nc euphora rx ptca balloon catheter.There were no abnormalities in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.It was reported that during preparation of the device in vitro, the shaft broke in 2 parts about 1/3 of the way back from the balloon end of the device.The device never entered the patient¿s body.Patient status post-procedure is alive with no injury.Device returned with blood present and tip stubbed which indicates use in patient, could not be confirmed with account.

• 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: 7897492
• Report Number: 9612164-2018-02475
• Device Sequence Number: 16496786
• Product Code: LOX
• UDI-Device Identifier: 00643169396203
• UDI-Public: 00643169396203
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: 01/10/2019
• Device Catalogue Number: NCEUP4020X
• Device Lot Number: 212585047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1