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Catalog Number RBY2C1660 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was detached from its pusher assembly and stuck inside the returned lantern.The proximal constraint sphere was not present inside the distal detachment tip (ddt) and the ddt was damaged.Conclusions: evaluation of the returned ruby coils revealed kinked pusher assemblies.If the ruby coils are forcefully advanced against resistance the pusher assembly may become kinked.The ovalization in the returned lantern likely contributed to the resistance experienced during the procedure.Further evaluation revealed the second ruby coil evaluated was detached.If the ruby coil is forcefully advanced into the lantern ovalization, additional resistance may be experienced upon attempts to retract the device.If the ruby coil is forcefully retracted against resistance the embolization coil may become detached.Further evaluation also revealed the ddt was damaged.The root cause of the damaged ddt could not be determined.Penumbra coils and catheters are visually 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: 3005168196-2018-01757; 3005168196-2018-01758; 3005168196-2018-01760.
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Event Description
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The patient was undergoing a coil embolization procedure in the splenic artery 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 ruby coil became stuck; therefore, it was removed.It was reported that the same issue occurred with two other ruby coils; therefore, the lantern and ruby coils were removed.The procedure was completed using a new lantern and other coils.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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