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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH

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COOK, INC. CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH Back to Search Results
Catalog Number CXI-4.0-35-90-P-NS-DAV
Device Problem Tip breakage (1638)
Patient Problem Foreign body, removal of (2365)
Event Date 04/01/2014
Event Type  malfunction  
Event Description
A patient underwent an interventional procedure on (b)(6) 2014.Right femoral artery was punctured and the cxi support catheter was inserted over a 0.035 inch radifocus wire guide with antegrade approach.Moreover, a zeon x support catheter was inserted with distal sfa direct puncture.When the cxi support catheter was advanced with rotation, the tip of the catheter was caught and separated at the point about 15cm from the tip.It was removed with a snare and forceps; then a second cxi support catheter was used.However, the lumen was pressed and kinked due to calcification during advancement.The physician was not able to advance it further and he used another manufacturer's device for replacement.No adverse effect to the patient.The physician stated that he usually advances the catheter with rotation and this time the tip caught and separated.He stated that if he had been more careful this event may not have happened.In the case of the second cxi support catheter the physician started that he had advanced with force since calcification was severe.
 
Manufacturer Narrative
(b)(4).Event evaluation: still under investigation.
 
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Brand Name
CXI SUPPORT CATHETER
Type of Device
KRA CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
COOK, INC.
bloomington IN 47404
Manufacturer Contact
rita harden, director
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key3821169
MDR Text Key4504192
Report Number1820334-2014-00183
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K072724
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 04/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2016
Device Catalogue NumberCXI-4.0-35-90-P-NS-DAV
Device Lot Number4427803 OR 4399061
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/17/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/03/2014
Device AgeMO
Event Location Hospital
Initial Date Manufacturer Received 04/03/2014
Initial Date FDA Received04/30/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/07/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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