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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 PXSLIMLAN135STR
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2021
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) and angiographic catheter. It was noted that the patient¿s anatomy was tortuous. During the procedure, the physician was experiencing gradual resistance while advancing a lantern through the angiographic catheter. Therefore, the physician decided to remove the lantern. However, while retracting the lantern against resistance, the distal tip of lantern broke off within the angiographic catheter. Therefore, the angiographic catheter was removed containing the broken tip lantern. The procedure was completed using a new lantern and the same angiographic catheter. 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 Key12036885
MDR Text Key257496489
Report Number3005168196-2021-01375
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 01/01/2005,05/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPXSLIMLAN135STR
Device Catalogue NumberPXSLIMLAN135STR
Device Lot NumberF100548
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 Received06/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2020
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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