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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
Model Number PXSLIMLAN135T45
Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
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
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a lantern delivery microcatheter (lantern), a non-penumbra catheter, and a non-penumbra sheath. It should be noted that the patent's anatomy was tortuous, narrowed, and calcified. During the procedure, resistance was encountered while advancing the lantern through the catheter and subsequently, the lantern became kinked. Upon retrieval, the distal part of the lantern broke inside the parent catheter. It was also noted that the parent catheter was still inside the patient when the lantern break occurred. The procedure was completed using a new lantern, one pod coil, three pod packing coils (pod pcs) and the same catheter and sheath. There was no report of an adverse effect to the patient.
 
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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 Key12080004
MDR Text Key259226026
Report Number3005168196-2021-01424
Device Sequence Number1
Product Code DQY
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K152840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,05/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPXSLIMLAN135T45
Device Catalogue NumberPXSLIMLAN135T45
Device Lot NumberF103550
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2021
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 Received07/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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