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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 PXSLIMLAN150STR
Device Problems Kinked (1339); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2018
Event Type  Malfunction  
Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return. 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 number: 3005168196-2018-01009. The hospital discarded the device.

 
Event Description

The patient was undergoing a coil embolization procedure in the subclavian artery using a lantern delivery microcatheter (lantern) and ruby coils. During the procedure, the physician successfully placed one ruby coil using the lantern. The physician then felt resistance while advancing another ruby coil through the lantern and, consequently, the pusher assembly of the ruby coil became kinked. The physician, therefore, removed the ruby coil and lantern and noticed that the proximal end of the lantern had become kinked near the hub of the non-penumbra catheter. The procedure was completed using a new microcatheter, the same sheath, new ruby coils, and additional coils. 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 Key7527992
MDR Text Key108729822
Report Number3005168196-2018-01008
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK152840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPXSLIMLAN150STR
Device LOT NumberF81813
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 Received04/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/08/2018
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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