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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION MAGNETIC RETRIEVER SYSTEM
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ATRICURE, INC. COBRA FUSION MAGNETIC RETRIEVER SYSTEM Back to Search Results
Model Number 001-700-003
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2016
Event Type  malfunction  
Manufacturer Narrative
Complaint number: (b)(4).The device was received and sent to atricure engineering for analysis.All components of the items returned were intact.The magnet caps/ holders and yokes were all undamaged and secured to the braided tubing on the introducer and retriever.The yokes/ sleeves on the positioners were also undamaged and secured to their hypotubes.The complaint could not be confirmed.
 
Event Description
Per the customer, broken magnet with the cobra fusion unit.During procedure peeling from the tip of the magnet guide.
 
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Brand Name
COBRA FUSION MAGNETIC RETRIEVER SYSTEM
Type of Device
COBRA FUSION MAGNETIC RETRIEVER SYSTEM
Manufacturer (Section D)
ATRICURE, INC.
7555 innovation way
mason OH 45040
Manufacturer Contact
ranjana iyer
7555 innovation way
mason, OH 45040
5137555320
MDR Report Key5887323
MDR Text Key52511615
Report Number3003502395-2016-00092
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 07/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number001-700-003
Device Catalogue Number001-700-003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/20/2016
Initial Date FDA Received08/18/2016
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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