MAUDE Adverse Event Report: ESTECH COBRA FUSION 150 MI ABLATION SYSTEM; COBRA FUSION 150 ABLASIAN SYSTEM

Model Number 700-001MI

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2014

Event Type  malfunction  

Event Description

The surgeon placed the device and applied energy successfully, suction was turned off and a frame shift was done, suction applied again, and energy applied again, suction turned off, and a frame shift in the other direction was done.At this point energy was applied to electrodes 1, 2, 3 bipolar and monopolar, then 4, 5, 6 bipolar, but the esu was timing out and unable to maintain temperature.Troubleshooting and repositioning did not help so a monopolar burn was done which was successful, tried another bipolar burn, the same issue.The surgeon at this point noticed that something had come out of the probe that appeared to be an electrode.It was taken off the field, the device was removed and inspected for damage.It appeared that the electrode found was the only damage so the device was replaced with a new device.The new device was placed on the introducer via magnet introducer and began routing, as the surgeon pulled, the introducer and fusion came apart.While the surgeon was rerouting the introducer, the introducer magnet was attached to the end of the fusion.The surgeon removed the white tip introducer and replaced it with the grey tip.The grey tip introducer was used to place the fusion and the burn was completed; tested, at which point block was not achieved in the rspv so one more round of energy was applied to the probe and tested again, block was achieved in the rspv and ripv at this point.The second device was now removed and inspected, it appeared that the electrodes had not detached, but were coming out of the probe (not sitting sung against the wall).There was no harm to the patient and the procedure was ultimately able to be completed successfully.

• Brand Name: COBRA FUSION 150 MI ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLASIAN SYSTEM
• Manufacturer (Section D): ESTECH; san ramon CA
• Manufacturer Contact: 2603 camino ramon; ste 100; san ramon, CA 94583 ; 9258667111
• MDR Report Key: 3894137
• MDR Text Key: 4675956
• Report Number: 2953686-2014-00002
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2014

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 Expiration Date: 03/12/2016
• Device Model Number: 700-001MI
• Device Catalogue Number: 001-700-001MI
• Device Lot Number: 12079-031213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention