Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE INC. COBRA FUSION 150 ABLATION SYSTEM; COBRA FUSION 150 SURGICAL SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRICURE INC. COBRA FUSION 150 ABLATION SYSTEM; COBRA FUSION 150 SURGICAL SYSTEM Back to Search Results
Model Number 001-700-001S
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was received and sent to (b)(4) for analysis.The complaint was confirmed, upon evaluation the distal face of the magnet cap had failed resulting in the magnet pulling from the distal end of the probe.The complaint was confirmed.
 
Event Description
During a maze procedure the magnet from fusion 150 came out of the catheter portion of fusion and stuck on the introducer.The procedure was prolonged three minutes and another like device was used to complete the case.The patient outcome was not affected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COBRA FUSION 150 ABLATION SYSTEM
Type of Device
COBRA FUSION 150 SURGICAL SYSTEM
Manufacturer (Section D)
ATRICURE INC.
6217 centre park drive
west chester OH 45069 3886
Manufacturer Contact
ranjana iyer
6217 centre park drive
west chest, OH 45069-3886
MDR Report Key5798804
MDR Text Key49756536
Report Number3003502395-2016-00040
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
Reporter Country CodeUS
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 11/05/2015
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 No Information
Device Model Number001-700-001S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/05/2015
Initial Date FDA Received07/15/2016
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
-
-