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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 Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
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 using a lantern delivery microcatheter (lantern), a non-penumbra catheter, and a guidewire. During the procedure, while advancing the lantern in the catheter, the physician experienced resistance. Therefore, the lantern was removed. The procedure was completed using another lantern and the same catheter. There was no report of an adverse effect to the patient.

 
Manufacturer Narrative

Evaluation of the returned lantern revealed a distal shaft ovalization. If the peel-able sheath (supplied by penumbra) is not properly used to protect the distal shaft of the lantern during insertion into a parent device, and the lantern is forcefully gripped or pinched, damage such as a distal shaft ovalization may occur. This ovalization likely contributed to the difficulty advancing the lantern during the procedure. During functional testing, the lantern was able to advance through a demonstration benchmark without issue. Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
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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 Key12375126
MDR Text Key268450295
Report Number3005168196-2021-01905
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 01/01/2005,09/28/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPXSLIMLAN135T45
Device Catalogue NumberPXSLIMLAN135T45
Device LOT NumberF104601
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 Received09/02/2021
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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