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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
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2018
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed. This report is associated with mfr report numbers: 3005168196-2018-01086, 3005168196-2018-01087. The hospital discarded the device.

 
Event Description

The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern). During the procedure, the physician successfully deployed and detached a ruby coil in the target vessel using a lantern. While attempting to advance a new ruby coil through the lantern, the physician experienced resistance and the ruby coil would not advance; therefore, it was removed. The physician then successfully placed another ruby coil in the target vessel using the same lantern. While attempting to advance the last ruby coil, the physician experienced resistance again and the ruby coil would not advance. Therefore, the lantern and ruby coil were removed and the procedure was ended. 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 Key7552877
MDR Text Key109515092
Report Number3005168196-2018-01088
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/08/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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