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Adverse Event Report

COOK INCORPORATED EMBOLIZATION COIL SYSTEM   back to search results
Catalog Number DCS-18-6-30-J
Device Problem Premature deployment
Event Date 10/15/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

The customer returned the embolization coil in an opened and used condition. Investigation revealed that the most proximal 2cm are bent. Based upon the information provided by the customer concerning this matter, the cook ifu t-dcs201 states the following: "to avoid binding the coil inside the microcatheter, you must rotate the locking device very slowly. " the appropriate personnel have been advised of this matter.

 
Event Description

During the detachment test, the coil backed up slightly, then released. The physician could not advance the coil back to the catheter tip. The coil proximal end was in the patient's vessel. The coil was captured and retrieved by "wrapping" a guide wire around the proximal end, then was removed.

 
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Brand NameEMBOLIZATION COIL SYSTEM
Type of DeviceEMBOLIZATION
Baseline Brand NameEMBOLIZATION COIL SYSTEM
Baseline Generic NameNA
Baseline Catalogue NumberDCS-18-6-30-J
Baseline Device FamilyEMBOLIZATION
Baseline Device 510(K) NumberK000651
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed11/01/2000
Manufacturer (Section F)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
Manufacturer Contact
rita harden
750 daniels way
bloomington , IN 47404
(812) 339 -2235
Device Event Key415845
MDR Report Key426822
Event Key403768
Report Number1820334-2002-00130
Device Sequence Number1
Product CodeHCG
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation RESPIRATORY THERAPIST
Type of Report Initial
Report Date 10/15/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/01/2005
Device Catalogue NumberDCS-18-6-30-J
Device LOT Number1059104
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/15/2002
Device Age18 mo
Event Location Hospital
Date Manufacturer Received10/15/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2001
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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