CXI SUPPORT CATHETER CXI-2.6-18-150-P-NS-0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for CXI SUPPORT CATHETER CXI-2.6-18-150-P-NS-0 manufactured by Cook Inc.

Event Text Entries

[183352589] Concomitant products: additional devices used includes a micropuncture to gain access and likely other catheters which were unspecified. Occupation: lab manager. Pma/510(k): k160884. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[183352590] It was reported that the hub of a cxi support catheter separated from the shaft of a catheter during a procedure. The access site for the wire was the femoral artery, but the target location remains unknown. While trying to cross an occlusion, there was a "heavy amount of torqueing and twisting". The shaft of the catheter then separated from the hub and the physician decided to remove the device. Another device was used to complete the procedure, and it was reported that this device also separated and had to be removed from the patient. The separation of the second device is reported in another mdr with patient ref number: (b)(6). A micropuncture was used to gain access, and other catheters were also used during the procedure. It is unknown if the patient's anatomy was tortuous or calcified. It was reported there were no adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00598
MDR Report Key9823760
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-02-11
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCXI SUPPORT CATHETER
Generic NameKRA CATHETER, CONTINUOUS FLUSH
Product CodeKRA
Date Received2020-03-12
Model NumberNA
Catalog NumberCXI-2.6-18-150-P-NS-0
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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