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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL COOK PERFORMER SHEATH COOK SHEATH

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COOK MEDICAL COOK PERFORMER SHEATH COOK SHEATH Back to Search Results
Catalog Number G08957
Device Problem Split (2537)
Patient Problem Blood Loss (2597)
Event Date 12/22/2017
Event Type  Injury  
Event Description
Pt in cardiac arrest urgently treated for total occlusion of rca with percutaneous intervention. Pt's condition declined and impella placement placed in right femoral artery to support cardiac output. A cook sheath was used to support the impella insertion and management. Pt had a loss of blood volume over the next 24-36 hours. The pt returned to surgery to find the source of bleeding and to remove the impella devise. Upon removal of the cook sheath, there was a crack across the tubing which was identified as the source of the blood loss.
 
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Brand NameCOOK PERFORMER SHEATH
Type of DeviceCOOK SHEATH
Manufacturer (Section D)
COOK MEDICAL
750 daniel way
bloomington IN 47404
MDR Report Key7211827
MDR Text Key98118283
Report Number7211827
Device Sequence Number1
Product Code DYB
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 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG08957
Device Lot Number8204919
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/22/2017
Device Age NA
Event Location Hospital
Date Report to Manufacturer01/08/2018
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/23/2018 Patient Sequence Number: 1
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