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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 Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2021
Event Type  Malfunction  
Manufacturer Narrative

This device is available for return. A follow up mdr will be submitted upon completion of the device investigation. This report is associated with mfr report numbers: 3005168196-2021-01874, 3005168196-2021-01875.

 
Event Description

The patient was undergoing a coil embolization procedure in the short gastric artery using ruby coils, a lantern delivery microcatheter (lantern), non-penumbra coils, and a non-penumbra catheter. During the procedure, the physician placed a ruby coil and two non-penumbra coils into the target location using the lantern. While advancing the next ruby coil through the lantern, the physician experienced resistance. Subsequently, the ruby coil became stuck in the middle of the lantern; therefore, the ruby coil was removed. Next, while advancing another ruby coil through the lantern, the same issue occurred. The physician experienced resistance and subsequently, the ruby coil became stuck in the middle of the lantern. Therefore, the ruby coil and the lantern were removed. The procedure was completed using four pod packing coils (pod pcs) and a new lantern. 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 Key12356214
MDR Text Key267850008
Report Number3005168196-2021-01876
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)Y
Reporter Country CodeJA
PMA/PMN NumberK152840
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 01/01/2005,09/30/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/23/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPXSLIMLAN135STR
Device Catalogue NumberPXSLIMLAN135STR
Device LOT NumberF104603
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/18/2021
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 Received08/31/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/16/2021
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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