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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 05/18/2021
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. This report is associated with mfr report numbers: 3005168196-2021-01348. 3005168196-2021-01349. 3005168196-2021-01350.
 
Event Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod packing coils (pod pcs) and lantern delivery microcatheters (lanterns). During the procedure, a pod pc was determined to be too long for the coil pack. When retracting the pod pc, the physician experienced resistance, and the pod pc unintentionally detached inside the lantern. The detached pod pc and lantern were then removed together. Subsequently, the physician was unable to flush the pod pc out of the lantern and decided to use a new lantern and new pod pc. The pod pc was also determined to be too long for the coil pack. When retracting the pod pc, the physician experienced resistance, and the pod pc unintentionally detached inside the lantern. The detached pod pc and lantern were then removed together. No additional information regarding the completion of the procedure was provided. 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 Key12014238
MDR Text Key259471611
Report Number3005168196-2021-01351
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
Report Date 01/01/2005,06/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPXSLIMLAN135T45
Device Catalogue NumberPXSLIMLAN135T45
Device Lot NumberF102811
Was Device Available for Evaluation? No
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 Received05/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2020
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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