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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC CANTATA 2.9 SUPERSELECTIVE MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH
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COOK INC CANTATA 2.9 SUPERSELECTIVE MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH Back to Search Results
Catalog Number MCS-2.9-NT-135-15-HP
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 10/07/2015
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
The user noted that the device was leaking from the hub prior to the procedure.
 
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Brand Name
CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
Type of Device
KRA CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6993421
MDR Text Key91926448
Report Number1820334-2017-03807
Device Sequence Number1
Product Code KRA
UDI-Device Identifier10827002345826
UDI-Public(01)10827002345826(17)160901(10)4737647
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberMCS-2.9-NT-135-15-HP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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