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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 07/05/2021
Event Type  Malfunction  
Manufacturer Narrative

The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation. This report is associated with mfr report number: 3005168196-2021-01707.

 
Event Description

The patient was undergoing a coil embolization procedure in the superior and inferior gluteal arteries using ruby coils, a lantern delivery microcatheter (lantern), and a non-penumbra catheter. It should be noted that the patient's anatomy was tortuous, calcified, and narrowed. During the procedure, the physician successfully implanted one ruby coil in the superior gluteal artery. While advancing the next ruby coil over the hub of the microcatheter, resistance was encountered. However, the distal tip of the ruby coil was able to advance past the hub. The ruby coil was retracted and re-advanced; however, resistance was encountered while advancing the coil over the same location. Subsequently, the physician inadvertently kinked the ruby coil pusher assembly. Therefore, the ruby coil was removed. Next, a ruby coil became stuck during advancement through the lantern; therefore the lantern containing the ruby coil was removed from the patient. Subsequently, a non-penumbra microcatheter was used to successfully implant the same ruby coil. The procedure was completed using two ruby coils and two pod packing coils (pod pcs) to embolize the superior gluteal artery and three ruby coils and two pod pcs to embolize the inferior gluteal artery with the same non-penumbra microcatheter. 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 Key12257239
MDR Text Key264494103
Report Number3005168196-2021-01708
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)Y
Reporter Country CodeJA
PMA/PMN NumberK152840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,08/24/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPXSLIMLAN135T45
Device Catalogue NumberPXSLIMLAN135T45
Device LOT NumberF103550
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/13/2021
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 Received08/04/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/27/2021
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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