MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SYNERGY ACCESS CLAMP

Model Number EMT1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not yet been returned to atricure for evaluation.If additional information is received a supplemental report will be submitted.Have not received the device.

Event Description

During a maze procedure, after completing pvi lesion, the surgeon proceeded to ablate mitral valve ring using the emt1 device.The jaw of the clamp would not open when release button was pressed.The physician had not experienced this before so he opened the jaw with his hands and took the clamp out.He proceeded to complete the lesion using clamp when there was an a error alarm.A pen was used to complete remaining lesions.The procedure was completed and the patient was taken off-pump.At the same time, physician noticed bleeding from left atria.Patient was put back on-pump to repair and stop bleeding prolonging the procedure.Patient also received blood transfusion (amount unknown).The physician commented that it appeared that injury occurred during the removal of clamp from mitral valve ring.

Manufacturer Narrative

(b)(4).The device was received and sent to atricure engineering for analysis.Upon inspection of the clamp, it was determined that the proximal end of the drive bar and the distal end of the plunger were broken.A broken drive bar and/or plunger will cause the return spring to open and the plunger is then able to open past the normal open position which can cause the proximal rf wires to break.The complaint is confirmed.

• Brand Name: ISOLATOR SYNERGY ACCESS CLAMP
• Type of Device: ISOLATOR SYNERGY ACCESS CLAMP
• 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 Key: 5613671
• MDR Text Key: 43840549
• Report Number: 3003502395-2016-00021
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EMT1
• Device Catalogue Number: A000602
• Device Lot Number: 60143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• 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 Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention