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U.S. Department of Health and Human Services

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

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COOK, INC. COOK SPECTRUM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number G49802
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Stroke/CVA (1770)
Event Date 03/25/2016
Event Type  Injury  
Event Description
New central venous line confirmed by x-ray as located in superior vena cava (vein). Patient with altered mental status approximately 4 days later leading to activation of code stroke. Cat scan reveals catheter is actually in the innominate artery and patient suffered watershed stroke in the anterior cerebral artery (aca) and middle cerebral artery (mca) territory. Line removed immediately.
 
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Brand NameCOOK SPECTRUM
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK, INC.
750 daniels way
blooomington IN 47402
MDR Report Key5610900
MDR Text Key43730649
Report Number5610900
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberG49802
Device Lot Number6271915
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2016
Event Location Hospital
Date Report to Manufacturer04/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/27/2016 Patient Sequence Number: 1
Treatment
CARDIAC DRUGS
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