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

Catalog Number	NCEUP3520X
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	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure it was intended to use an nc euphora rx ptca balloon catheter was been used to treat a lesion.It was reported that the device broke in the guide catheter and failed to cross the lesion.There is no patient injury reported.
Additional Manufacturer Narrative
Device evaluation summary: the device returned with a detachment on the transition shaft 5.4cm distal to the proximal end of the transition shaft.There was 11.6cm of the core wire was exposed.The transition shaft was stretched and kinked.The transition shaft material was jagged on both sides of the detachment site.Deformation was evident to the distal tip, there was no detachment of the tip material.The balloon folds were expanded; inflation had been performed.The balloon bond appeared necked.There was no damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
No damage was noted to packaging.There was no issues noted when removing the device from the hoop.The device failed to cross the lesion.It was reported that the device broke in the guide catheter.The guide was kinked.When attempting to remove the balloon the catheter got caught.The detachment happened in the guide and the tip came off during the removal of the device from the guide catheter.No portion of device remains in patient.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: 8758207
• Report Number: 9612164-2019-02678
• Device Sequence Number: 11393831
• Product Code: LOX
• UDI-Device Identifier: 00643169396326
• UDI-Public: 00643169396326
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2019

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: 05/01/2021
• Device Catalogue Number: NCEUP3520X
• Device Lot Number: 217630413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/11/2019; 09/10/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/09/2019; 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 90