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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERSECT ENT PROPEL CONTOUR MOMETASONE FUROATE IMPLANTABLE; DRUG-ELUTING SINUS STENT
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INTERSECT ENT PROPEL CONTOUR MOMETASONE FUROATE IMPLANTABLE; DRUG-ELUTING SINUS STENT Back to Search Results
Catalog Number 50011
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/13/2020
Event Type  malfunction  
Event Description
There was no harm to the patient.The surgeon, while attempting to deploy the device, was notified it was not working correctly.The device was removed from the field and another device obtained.The faulty device was sequestered to provide to the rep/vendor for replacement.
 
Event Description
There was no harm to the patient.The surgeon, while attempting to deploy the device, was notified it was not working correctly.The device was removed from the field and another device obtained.The faulty device was sequestered to provide to the rep/vendor for replacement.
 
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Brand Name
PROPEL CONTOUR MOMETASONE FUROATE IMPLANTABLE
Type of Device
DRUG-ELUTING SINUS STENT
Manufacturer (Section D)
INTERSECT ENT
1555 adams drive
menlo park CA 94025
MDR Report Key9896920
MDR Text Key185517283
Report Number9896920
Device Sequence Number1
Product Code OWO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number50011
Device Lot Number90429002
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2020
Event Location Hospital
Date Report to Manufacturer03/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age25185 DA
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