Catalog Number PXSLIMLAN135T45 |
Device Problems
Collapse (1099); Failure to Advance (2524); Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
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Event Description
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The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using a lantern delivery microcatheter (lantern).During the procedure, the physician encountered resistance and was unable to advance the lantern over a guidewire and, therefore, the lantern was removed.Upon removal, the hospital staff noticed that the lantern was "collapsed" 15 mm from the tip.The procedure was then completed using the same guidewire and a new lantern.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Results: the returned device was ovalized at approximately 133.0 cm from the hub.Conclusions: evaluation of the returned lantern revealed an ovalization on the distal shaft of the catheter.If the device is forcefully gripped or pinched during the procedure, damage such as this may occur.The ovalization on the catheter likely contributed the resistance while advancing the lantern over the guidewire.During functional testing, a test mandrel was inserted through the returned lantern and resistance was experienced at the ovalized location on the catheter.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.
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Search Alerts/Recalls
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