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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. CELECT PLATINUM FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK, INC. CELECT PLATINUM FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G343091
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Information (3190)
Event Date 07/25/2017
Event Type  malfunction  
Event Description
The inferior vena cava (ivc) filter device was not able to release from delivery system by operator: lidocaine 1% was infused for local anesthesia. Right internal jugular vein was patent by real-time sonography. Micropuncture technique was used to access the right internal jugular vein. The celect sheath was advanced into the right common iliac vein, and ivc gram was performed, revealing no evidence for thrombus in the imaged ivc. Under fluoroscopic guidance, the filter was deployed. Initially, there was difficulty deploying the filter: after the safety button was pressed, the second deployment mechanism did not work initially. We attempted to re-sheath the filter, but this was also not successful. Eventually, the mechanism did detach, and the filter was deployed in the infra-renal location, in the exact location that we intended to deploy the filter. Afterwards, we did not obtain an ivc gram, as the sheath was not functional.
 
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Brand NameCELECT PLATINUM
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK, INC.
750 daniels way
bloomington IN 47404
MDR Report Key6841471
MDR Text Key84639978
Report Number6841471
Device Sequence Number1
Product Code DTK
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 08/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG343091
Device Catalogue NumberG34309
Device Lot NumberE3585069
Other Device ID NumberIGTCFS-65-1-JUG-CELECT-PT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/17/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer08/17/2017
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

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