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

Model Number NCEUP27508X

Device Problems Hole In Material (1293); Radiation Leak (1357)

Patient Problem Angina (1710)

Event Date 09/28/2017

Event Type  malfunction  

Event Description

Micro hole in the balloon when inflated, may have led to septal dissection.Small pinhole leak causing contrast to leak out.Patient is stable.The rest of the case went well.Patient having mild angina post case.Staying over night.

• Brand Name: NC EUPHORA¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; gerardine finn; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 7066917
• MDR Text Key: 93215968
• Report Number: 7066917
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NCEUP27508X
• Device Catalogue Number: NCEUP27508X
• Device Lot Number: 213493756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2017
• Event Location: Other
• Date Report to Manufacturer: 11/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR