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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 07/22/2021
Event Type  Malfunction  
Manufacturer Narrative

Evaluation of the returned lantern confirmed a fracture on the mid-shaft. If the device is forcefully manipulated against resistance, damage such as a kink and subsequent fracture may occur. The root cause of resistance during the procedure could not be determined. No other damage was observed on the device. 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.

 
Event Description

The patient was undergoing a coil embolization procedure in the gonadal vein using a lantern delivery microcatheter (lantern) and a non-penumbra catheter. During the procedure, the physician was unable to advance the lantern out of the distal tip of the catheter. Therefore, the lantern was retracted out of the catheter, and the physician exchanged the catheter to another non-penumbra catheter. Next, while the physician attempted to advance the same lantern through the new catheter, the same issue occurred. The lantern was unable to advance out of the distal tip of the new catheter. Therefore, the physician removed the lantern and noticed that the lantern had broken into pieces. The procedure was completed using a new lantern and the same second 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 Key12328706
MDR Text Key266932087
Report Number3005168196-2021-01817
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK152840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/16/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/16/2021
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 NumberF105303
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/03/2021
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 Received07/22/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/12/2021
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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