Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH Back to Search Results
Catalog Number CXI-2.6-18-90-P-NS-ANG
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/29/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
It was reported that the wire guide got stuck in the cxi when the cxi was used for the procedure.It was further noted that the device unraveled.Another device was used to complete the procedure.There were no reported adverse effects to the patient as a result of this product problem.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CXI SUPPORT CATHETER
Common Device Name
KRA CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key6994506
Report Number1820334-2017-03816
Device Sequence Number1495867
Product Code KRA
UDI-Device Identifier00827002500020
UDI-Public(01)00827002500020(17)180408(10)5785502
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 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
Operator of Device Health Professional
Device Catalogue NumberCXI-2.6-18-90-P-NS-ANG
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/27/2017
Initial Report FDA Received Date11/01/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-