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Catalog Number 4004C0513 |
Device Problems
Failure to Advance (2524); Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/21/2017 |
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 penumbra coil 400 (pc400).The pusher assembly was kinked approximately 5.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured.The embolization coil was inside its introducer sheath.The sr wire was fractured and, therefore, both the pc400 was unable to be functionally tested for the ability to track inside a microcatheter.Conclusions: evaluation of both returned pc400s revealed that their sr wires were fractured.This type of damage typically occurs due to forceful retraction of the embolization coil against resistance.If the sr wire fractures, it will result in the unintentional detachment of the embolization coil.Further evaluation of both returned pc400s revealed that their pusher assemblies were kinked.These kinks were likely incidental and may have occurred while packaging the devices for return to penumbra.The px slim delivery microcatheter (px slim) mentioned in the complaint was not returned for evaluation.Penumbra coils 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 number: 3005168196-2017-02255.
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Event Description
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The patient was undergoing a coil embolization procedure in the superior gluteal artery using penumbra coil 400''s (pc400's).It was noted that the patient had slight calcification.During the procedure, the physician deployed and detached four initial pc400's into the target vessel using a px slim delivery microcatheter (px slim).While attempting to advance two new pc400's into the px slim, the physician connected the introducer sheath with the hub of the px slim and advanced the coils approximately twenty to thirty centimeters into px slim.The physician then felt scratching and was unable to advance the pc400's further.It was also reported that one of the pc400's unintentionally detached within the px slim.Therefore, the px slim containing the detached pc400 was removed, then the detached coil was removed from the px slim.Thereafter, the procedure was completed using the same px slim and fourteen new pc400s.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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