MAUDE Adverse Event Report: MEDTRONIC, INC. NC EUPHORA; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number NCEUP2512X

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2019

Event Type  malfunction  

Event Description

During a coronary intervention, physicians were attempting to insert a balloon into the body to perform a coronary angioplasty.The balloon catheter broke before entering the body.This occurred three times with three balloons, all the same brand and size.We used another balloon that worked.

• Brand Name: NC EUPHORA
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 8451286
• MDR Text Key: 139821123
• Report Number: 8451286
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NCEUP2512X
• Device Lot Number: 216906363
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA