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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
Catalog Number PXSLIMLAN135T90
Medical Device Problem Codes Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/07/2018
Type of Reportable Event Malfunction
Additional 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.The hospital disposed of the device.
 
Event or Problem Description
During preparation for a medical procedure, the physician found that the tip of the lantern delivery microcatheter (lantern) had irregular shape upon removal of the packaging mandrel.The reported issue was found prior to use.Therefore, the lantern was not used in the procedure.The procedure was completed using a new lantern.
 
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Brand Name
LANTERN DELIVERY MICROCATHETER
Common Device Name
DQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7657050
Report Number3005168196-2018-01316
Device Sequence Number13865969
Product Code DQY
UDI-Device Identifier00814548016665
UDI-Public00814548016665
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K152840
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Expiration Date01/29/2021
Device Catalogue NumberPXSLIMLAN135T90
Device Lot NumberF81657
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/07/2018
Initial Report FDA Received Date07/02/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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