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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 11/20/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The surgeon was performing a minimally invasive coronary bypass procedure via a medican sternotomy using a cts access mv stabilizer. The surgeon was attempting to stabilize the circumflex artery. Access was obtained by using deep pericardial sutures and elevating the heart upward and exposure to the heart was adequate. The stabilizer foot tip caused a puncture type would of approximately 1 cm into the epicardium. The pt was placed on cardiopulmonary bypass for reasons unrelated to this injury. The puncture wound was repaired with suture and the pt suffered no complications from this incident.

 
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 Key136080
MDR Report Key139368
Event Key131042
Report Number2953148-1997-00003
Device Sequence Number1
Product CodeDWS
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 12/18/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/1997
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 Received11/20/1997
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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