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Catalog Number PXSLIMLAN115T90
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/14/2018
Event Type  Malfunction  
Manufacturer Narrative

Results: the lantern was kinked approximately 6. 0 cm from the hub. Initially, the lantern was unable to be flushed. A demonstration coil was unable to be advanced past the proximal kink. A mandrel was advanced through the length of the catheter to facilitate the removal of the clot and flushing of the device. Subsequently, a demonstration coil was able to be advanced through the length of the returned lantern without issue. Conclusions: evaluation of the returned lantern revealed a kink on its proximal shaft. This kink may have been due to improper handling during preparation for use. During functional testing, a demonstration ruby coil was unable to be advanced past this proximal kink. After advancing a mandrel through the catheter to flush the device, the demonstration ruby coil was able to pass through the returned lantern without issue. Advancing the mandrel through the kink likely widened the lumen of the returned lantern resulting in the successful advancement of the demonstration ruby coil. If this kink was present during the procedure it would likely have contributed to the resistance experienced and early detachment of the embolization coils. Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing. 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: 3005168196-2018-01157, 3005168196-2018-01158, 3005168196-2018-01159.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern). During the procedure, the physician felt resistance while advancing a ruby coil through the lantern and, consequently, the ruby coil unintentionally detached within the lantern. The physician therefore removed the rotating hemostatic valve (rhv) to pull out the ruby coil from the lantern. The physician then successfully placed another ruby coil. The physician then felt resistance while advancing another ruby coil within the lantern and, consequently the ruby coil unintentionally detached within the lantern. The physician again was able to remove the ruby coil by hand after removing the rhv. The physician then switched to a new lantern and successfully placed multiple ruby coils. However, the physician then felt resistance while advancing another ruby coil within its introducer sheath and into the lantern and thought that the pusher assembly was damaged, though no specific damage was noticed. The physician therefore removed the ruby coil. The procedure was completed using additional ruby coils, pod coils, and the same lantern. There was no report of an adverse effect to the patient.

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Type of DeviceDQY
Manufacturer (Section D)
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
MDR Report Key7596690
MDR Text Key111012539
Report Number3005168196-2018-01160
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
Reporter Occupation
Type of Report Initial
Report Date 05/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date09/05/2020
Device Catalogue NumberPXSLIMLAN115T90
Device LOT NumberF79408
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/06/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial