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Adverse Event Report

COOK INCORPORATED PLEXOR CHECK-FLO INTRODUCER SET SHEATH SET   back to search results
Catalog Number KCFW-5.0-38-70-RB-RAABE
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 12/19/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

Customer returned one product in an opened and used condition. Product was decontaminated and being dried when 1. 2 cm of the distal end of the sheath pulled off. An examination of the 1. 2 cm sheath material found a hole in the sheath just proximal to the embedded marker band and an area where the sheath material appears to have melted off. Customer stated they were performing a endo-venus laser ablation of the saphenous vein when the hub of the sheath separated from the sheath material. An examination of the hub found the flare still firmly attached inside. An examination of the proximal end shows elongation of the wire and tears of the sheath material. This damage suggests the sheath was pulled more than its designed intent.

 
Event Description

Procedure was endo-venous laser ablation of the saphenous vein. Patient had no scar tissue nor abnormalities. Guidewire was placed into vein and dilator snapped into sheath with no problems. When doctor removed dilator and inserted laserfiber, half way into insertion, connector fell off. Physician was able to continue by holding connecting arm with fingers. When surgery was completed, doctor noticed tip of sheath had unravelled or broke. He was able to retrieve device without any fragments or parts left in patient. To this date, patient has not suffered any adverse conditions and is unaware of difficulties encountered.

 
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Brand NamePLEXOR CHECK-FLO INTRODUCER SET
Type of DeviceSHEATH SET
Baseline Brand NamePLEXOR CHECK-FLO INTRODUCER SET
Baseline Generic NameSHEATH SET
Baseline Catalogue NumberKCFW-5.0-38-70-RB-RAABE
Baseline Device 510(K) Number
Baseline Device PMA Number
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 Key427339
MDR Report Key438421
Event Key414905
Report Number1820334-2003-00005
Device Sequence Number1
Product CodeDYB
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 12/23/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/01/2005
Device Catalogue NumberKCFW-5.0-38-70-RB-RAABE
Device LOT NumberF1329696
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/19/2002
Device Age02 mo
Event Location Outpatient Treatment Facility
Date Manufacturer Received12/23/2002
Was Device Evaluated By Manufacturer? Yes
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 December 31, 2008

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