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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND ATTAIN CLARITY; CATHETER, FLOW DIRECTED Back to Search Results
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).
 
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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 Key4834556
MDR Text Key5905710
Report Number9612164-2015-00942
Device Sequence Number1
Product Code DYG
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/17/2016
Device Model Number6225I
Device Catalogue Number6225I
Device Lot Number0007261272
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/06/2015
Initial Date FDA Received06/10/2015
Date Device Manufactured08/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age00067 YR
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