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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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COOK INC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Material Separation (1562); Unraveled Material (1664)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/05/2021
Event Type  Injury  
Manufacturer Narrative
Brand name: cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set. 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 guide of a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set broke inside a (b)(6) year-old, male patient. The device was being placed in the femoral vein for vasoactive/inotropic support for a cervical spinal cord injury. Initially, the procedure was reportedly straightforward. On withdrawing the "second dilator," the guidewire uncoiled and separated. A provided x-ray image also showed an unraveled guidewire. The separated section of the device was removed in an additional procedure by interventional radiology. A delay in placement of the cvc also lead to peripheral administration of vasoactive support with subsequent extravasation. No other adverse effects were reported.
 
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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 Key12672755
MDR Text Key277657519
Report Number1820334-2021-02364
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
PMA/PMN Number
K081113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
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-ABRM-HC-RD
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/21/2021 Patient Sequence Number: 1
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