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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM
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ATRICURE, INC. COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM Back to Search Results
Model Number 001-700-001MI
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2015
Event Type  malfunction  
Manufacturer Narrative
Complaint number: (b)(4).The device was received and sent to atricure engineering for analysis, the complaint was confirmed.The fusion 150 magnet cap crack and magnet dislodgement.
 
Event Description
It was reported that during the procedure, the magnetic tip, present on the fusion 150, had disconnected from its top and had remained connected to the rigid magnetic guide.Patient was off pump and care was not affected and there was no delay in case.Case was completed with the original device.
 
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Brand Name
COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM
Type of Device
COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM
Manufacturer (Section D)
ATRICURE, INC.
6217 centre park drive
west chester OH 45069 3886
Manufacturer Contact
ranjana iyer
6217 centre park drive
west chester, OH 45069-3886
5137555320
MDR Report Key5798883
MDR Text Key49758450
Report Number3003502395-2016-00043
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K113475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 11/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number001-700-001MI
Device Catalogue Number001-700-001MI
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received11/14/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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