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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-2.6-18-150-P-NS-0
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2016
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 device was advanced from the right fa (femoral artery) to the severely calcified lesion.When the user was advancing the device through the lesion, a wire guide got stuck inside the cxi.This was possibly due to the inner lumen of the cxi becoming narrowed due to advancement while applying a twist to the device.It was further noted that the device was stretched.Another cxi device was used to complete the procedure.There were no reported adverse effects to the patient as a result of this product problem.
 
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Brand Name
CXI SUPPORT CATHETER
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 Key6994365
MDR Text Key91928050
Report Number1820334-2017-03814
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00827002500013
UDI-Public(01)00827002500013(17)190315(10)6811750
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Physician
Type of Report Initial
Report Date 11/01/2017
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 Catalogue NumberCXI-2.6-18-150-P-NS-0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2017
Initial Date FDA Received11/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2016
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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