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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. LANTERN DELIVERY MICROCATHETER DQY

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PENUMBRA, INC. LANTERN DELIVERY MICROCATHETER DQY Back to Search Results
Catalog Number PXSLIMLAN150T90
Device Problems Break (1069); Material Perforation (2205); Physical Resistance/Sticking (4012)
Patient Problem No Patient Involvement (2645)
Event Date 02/21/2019
Event Type  Malfunction  
Manufacturer Narrative

The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

During preparation for a medical procedure using a lantern delivery microcatheter (lantern), while placing the lantern over a non-penumbra guidewire, the physician experienced resistance and the guidewire was found to have perforated through the lantern; consequently, the lantern had broken in half. The damage to the lantern occurred prior to use and prior to inserting it into the patient¿s body; therefore, it was not used in the procedure. The procedure was completed using a new lantern with the same guidewire.

 
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Brand NameLANTERN DELIVERY MICROCATHETER
Type of DeviceDQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key8445147
MDR Text Key139601904
Report Number3005168196-2019-00535
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK152840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,02/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPXSLIMLAN150T90
Device LOT NumberF83804
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/27/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received04/17/2019
Date Device Manufactured06/04/2018
Is this a Reprocessed and Reused Single-Use Device? No

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