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Catalog Number RBYPODJ15 |
Device Problems
Failure to Advance (2524); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was detached from its pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned podj revealed that the pet lock was broken and the embolization coil was detached from its pusher assembly.If the pusher assembly is forcefully retracted by the proximal end where the pet lock is located, damage such as a broken pet lock may occur.If the pet lock is broken and the pull wire is retracted out of the ddt, the embolization coil will detach from its pusher assembly.The embolization coil and the lantern identified in the complaint were not returned for evaluation.Therefore, the root cause of the reported complaint could not be determined.Further evaluation of the podj revealed that the pusher assembly was kinked.This kink was likely incidental and may have occurred while packaging the device for return to penumbra.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.
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Event Description
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The patient was undergoing a coil embolization procedure to treat gastric varices using a pod packing coil (podj).During the procedure, while attempting to advance a podj through a lantern delivery microcatheter (lantern), the initial pushes were very smooth, but thereafter, the podj just completely stopped; therefore, the lantern and podj were removed.It was reported that the podj introducer sheath might have not been off completely and that the physician was accidentally pushing the introducer sheath with the pusher assembly.The procedure was completed using other coils.There was no noted damage to the lantern after removal.Additionally, there was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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