MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN CLARITY; CATHETER, FLOW DIRECTED

Model Number 6225I

Device Problem Deflation Problem (1149)

Patient Problem Vascular Dissection (3160)

Event Date 03/05/2015

Event Type  Injury  

Event Description

It was reported that during the implant procedure, the inflated balloon remained occlusive and slowly moved proximally.The patient developed a dissection of the coronary sinus.The patient remained hospitalized.No further complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

• Brand Name: ATTAIN CLARITY
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4834556
• MDR Text Key: 5905710
• Report Number: 9612164-2015-00942
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2016
• Device Model Number: 6225I
• Device Catalogue Number: 6225I
• Device Lot Number: 0007261272
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2015
• Date Device Manufactured: 08/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 00067 YR