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Adverse Event Report

CARDIOTHORACIC SYSTEMS, INC. CTS ACCESS MV PLATFORM AND STABILIZER ARTERIAL STABILIZER   back to search results
Catalog Number CMS-175
Event Date 11/11/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The surgeon was performing his first opcab (off-pump coronary artery bypass) case with cts instruments. The surgeon performed a sternotomy incision and utilized the cts access mv stabilizer for performing a minimally invasive bypass procedure. The patinet was moderatley obese with an extremely larger heart. When the heart was positioned with gauze and the stabilizer was placed on the left lateral surface of the heart there was a larger amount of tissue spilling over the top of the stabilizer foot, this coupled with the beating motion of the heart, caused the superior portion of the stabilizer foot to damage the epicardium. A single pledgeted suture was used to repair this. The stabilizer was repositioned, and the anastomosis was constructed without incident. The additional anastomoses were completed without any complications. No clinical sequelae resulted.

 
Manufacturer Narrative

Na.

 
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Brand NameCTS ACCESS MV PLATFORM AND STABILIZER
Type of DeviceARTERIAL STABILIZER
Baseline Brand NameCTS ACCESS MV PLATFORM AND STABILIZER
Baseline Generic NameARTERIAL STABILIZER
Baseline Catalogue NumberCMS-175
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CARDIOTHORACIC SYSTEMS, INC.
10600 north tantau ave.
cupertino CA 95014
Manufacturer (Section D)
CARDIOTHORACIC SYSTEMS, INC.
10600 north tantau ave.
cupertino CA 95014
Manufacturer (Section G)
GUIDANT CORPORATION, CARDIAC SURGERY
3200 lakeside dr.
santa clara CA 95054
Device Event Key134885
MDR Report Key138116
Event Key129861
Report Number2953148-1997-00002
Device Sequence Number1
Product CodeDWS
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 12/11/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberCMS-175
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/11/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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