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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 PXSLIMLAN115T45
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  Injury  
Manufacturer Narrative
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.
 
Event Description
The patient was undergoing a coil embolization procedure to treat a left leg arteriovenous malformation (avm) off the superficial femoral artery (sfa) using a lantern delivery microcatheter (lantern) and an embolic agent. During the procedure, the physician injected an embolic agent through the lantern for several minutes. Then, the physician attempted to remove the lantern; however, the lantern was stuck due to the embolic agent that was used. Therefore, the physician pulled the lantern back with force. Upon removal of the lantern from the patient, the physician noticed it was broken. The physician then noticed under fluoroscopy that the lantern broke off at the radiopaque marker band located at the distal tip in the sfa. The physician attempted to use a snare device to retrieve the broken tip of the lantern; however, it was unsuccessful. Subsequently, the physician pushed the broken tip of the lantern deep into the avm using the snare device. It was reported that the broken tip of the lantern was left in the avm and that the physician was not worried about it remaining in the avm because it did not have a channel to travel anywhere else in the body. The procedure was completed using a new lantern and an embolic agent. 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 Key12072200
MDR Text Key259472708
Report Number3005168196-2021-01421
Device Sequence Number1
Product Code DQY
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K152840
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 01/01/2005,08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPXSLIMLAN115T45
Device Catalogue NumberPXSLIMLAN115T45
Device Lot NumberF89804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2021
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 Received08/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/25/2021 Patient Sequence Number: 1
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