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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. CXI SUPPORT CATHETER; KRA CATHETER, CONTINOUS FLUSH
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COOK, INC. CXI SUPPORT CATHETER; KRA CATHETER, CONTINOUS FLUSH Back to Search Results
Model Number N/A
Device Problem Tip breakage (1638)
Patient Problem Foreign body, removal of (2365)
Event Date 05/05/2014
Event Type  Injury  
Event Description
On (b)(6) 2014, a patient underwent a below the knee procedure.There was a difficult lesion to cross requiring a lot of manipulation and twisting of the cxi catheter resulting in a few cm distally breaking off.They used a snare to get it out successfully.Total procedure time was 4.5 hours.The complainant did not report any adverse effects on the patient due to this occurrence.
 
Manufacturer Narrative
(b)(4).Event evaluation: still under investigation.
 
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Brand Name
CXI SUPPORT CATHETER
Type of Device
KRA CATHETER, CONTINOUS FLUSH
Manufacturer (Section D)
COOK, INC.
bloomington IN 47402
Manufacturer Contact
rita harden
750 daniels way
bloomington, IN 47402
MDR Report Key3853521
MDR Text Key16060853
Report Number1820334-2014-00232
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K072724
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Unknown
Type of Report Initial
Report Date 05/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date05/31/2016
Device Model NumberN/A
Device Catalogue NumberCXI-2.6-18-150-P-NS-0
Device Lot Number4249713
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/27/2014
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/05/2014
Event Location Hospital
Date Manufacturer Received05/08/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/10/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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