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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN COMMAND CATHETER, PERCUTANEOUS

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MEDTRONIC, INC. ATTAIN COMMAND CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6250V-3D
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Perforation of Vessels (2135)
Event Date 02/05/2018
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the implant procedure was aborted due to complications. Additional information was requested, and it was learned there was difficulty locating a target branch. It was also reported the guide wire, catheter, and lead continually slipped out of the coronary sinus, the procedure lasted for hours, and the patient endured perforations due to wire placements. A review of the manufacturers data base revealed the patient is deceased. No other information is known at this time.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameATTAIN COMMAND
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7303110
MDR Text Key101166073
Report Number2182208-2018-00320
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6250V-3D
Device Catalogue Number6250V-3D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/28/2018 Patient Sequence Number: 1
Treatment
4298 LEAD, UNKNOWN COMPETITOR GUIDE WIRE
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