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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FIVE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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COOK INC FIVE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Material Separation (1562)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 01/23/2021
Event Type  Injury  
Manufacturer Narrative
Suspect medical device: information provided by the customer identifies the device as a "pentalumen central venous catheter. " gpn/rpn remain unknown at this time. (b)(6). Initial reporter occupation: product specialist. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that the wire of a pentalumen central venous catheter broke off in a patient's arm during insertion into the right subclavian. Once the vein was catheterized, the metal guide was inserted via the "syringe" using the seldinger technique. The "syringe" was then removed. The dilator was inserted via the metal guide with rotary movement in order to enter the skin and soft tissue without incident. When removing the dilator, the metal guide broke, with the distal part extracted together with the dilator. Most of the guide in the central vascular territory was unable to be removed. Once the approach was suspended, the physician proceeded to get access to the femoral central venous system on the first attempt with a different catheter. A vascular surgeon was referred to check on the patient the next day and initiate an anticoagulant therapy. It was reported by the customer that the entire procedure was reviewed with the operator and there was no error or step skipping during the procedure that could have caused this event. The procedure was completed with aseptic technique, guided by anatomy, with venous puncture on the first try. It was a clean procedure with no technical setbacks. The wire remains in the arm of the patient. Additional information regarding patient outcome has been requested, but is currently unavailable.
 
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Brand NameFIVE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
Type of DeviceFOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11271989
MDR Text Key230028568
Report Number1820334-2021-00239
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodePE
PMA/PMN Number
K081113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberC-UQLM-1001J-RSC-RD
Device Lot Number13100434
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/03/2021 Patient Sequence Number: 1
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