MAUDE Adverse Event Report: ENDOSCOPIC TECHNOLOGIES COBRA FUSION 150 ABLATION SYSTEM

Model Number 700-001S

Device Problem Positioning Problem (3009)

Patient Problem Cardiac Perforation (2513)

Event Date 05/02/2014

Event Type  Injury  

Event Description

Aortic valve replacement with subsequent use of ablation system.During the placement of the ablation catheter, there was a perforation on the left atrium through a sharp, bent electrode.

Manufacturer Narrative

Manufacturer has requested the device back from the healthcare facility.Device history records were reviewed.Picture of device sent to manufacturer was reviewed and showed extreme manipulation where the component assembly was torn.Instruction for use instructs the user only to grasp at the distal or proximal ends, away from the electrodes.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ENDOSCOPIC TECHNOLOGIES; san ramon CA
• Manufacturer Contact: innetta walker ; 2603 camino ramon; ste 100; san ramon, CA 94583 ; 9258667111
• MDR Report Key: 3912929
• MDR Text Key: 4588123
• Report Number: 2953686-2014-00008
• 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: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 700-001S
• Device Catalogue Number: 700-001S
• Device Lot Number: 12948-120213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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