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Adverse Event Report

CARDIAC SURGERY GUIDANT AORTIC PUNCH   back to search results
Model Number AP-4500
Event Date 02/14/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

During the coronary artery bypass graft surgery, while the surgeon was screwing on the punch on the left side of the aorta, their hand slipped causing a tear in the aorta. The surgeon used a side biter clamp to repair the tear using pledget sutures. No add'l pt complications were reported.

 
Manufacturer Narrative

Since the product will not be returned to guidant cardiac surgery for eval it will be difficult to confirm the reported problem.

 
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Brand NameGUIDANT AORTIC PUNCH
Baseline Brand NameGUIDANT AORTIC PUNCH
Baseline Generic NameVASCULAR CLAMP
Baseline Catalogue NumberAP-4500
Baseline Model NumberAP-4500
Baseline Device FamilyVASCULAR CLAMP
Baseline Device 510(K) NumberK022880
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)3
Date First Marketed09/13/2002
Manufacturer (Section F)
CARDIAC SURGERY
3200 lakeside dr.
santa clara CA 95054 2807
Manufacturer (Section D)
CARDIAC SURGERY
3200 lakeside dr.
santa clara CA 95054 2807
Manufacturer Contact
janine hanson
3200 lakeside dr
santa clara , CA 95054-2807
(888) 880 -2874
Device Event Key436895
MDR Report Key447928
Event Key424117
Report Number2953148-2003-00082
Device Sequence Number1
Product CodeDXC
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 02/14/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/31/2002
Device MODEL NumberAP-4500
Device Catalogue NumberAP-4500
Device LOT Number21018P2
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Hospital
Date Manufacturer Received02/14/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2002
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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