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

Catalog Number EUP2515X

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2017

Event Type  malfunction  

Event Description

A 2.5 by 15 mm euphora balloon was kinked in packaging and was unable to be advanced over the 0.014 wire.Never went in the body.

• Brand Name: EUPHORA
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC; chris harrold; 8200 coral sea st ne # mvs74; saint paul MN 55112
• MDR Report Key: 6724382
• MDR Text Key: 80438922
• Report Number: 6724382
• 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: Other
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: EUP2515X
• Device Lot Number: 212621115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1