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Adverse Event Report

CARDIAC SURGERY GUIDANT 4.5MM HEARTSTING PROXIMAL SEAL VASUCLAR CLAMP   back to search results
Model Number HS-1045
Event Date 03/18/2003
Event Type  Malfunction  
Event Description

The hospital reported that during preparation for a coronary artery bypass graft surgery, the hearstring seal cracked while loading into the delviery tube. The surgeon used a second heartstring seal to complete the procedure. No patient complications were reported by the hospital.

 
Manufacturer Narrative

Device was returned with the seal cracked between the second and third windings. The complaint is confirmed. Corrective action for cracked seals has been issued to further investigate and mitigate this failure.

 
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Brand NameGUIDANT 4.5MM HEARTSTING PROXIMAL SEAL
Type of DeviceVASUCLAR CLAMP
Baseline Brand NameGUIDANT HEARTSTRING
Baseline Generic NameVASCULAR CLAMP
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)12
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 drive
santa clara , CA 95054-2807
(888) 880 -2874
Device Event Key443017
MDR Report Key454013
Event Key430015
Report Number2953148-2003-00151
Device Sequence Number1
Product CodeDXC
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 03/18/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberHS-1045
Device Catalogue NumberHS-1045
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/24/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Hospital
Date Manufacturer Received03/18/2003
Was Device Evaluated By Manufacturer? Yes
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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