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Catalog Number RBY4C0835 |
Device Problems
Bent (1059); Failure to Advance (2524); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/05/2017 |
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 ruby coil pusher assembly.The ruby coil¿s pusher assembly was kinked approximately 35.0 cm from the proximal end.The ruby coil¿s embolization coil was intact with its pusher assembly and contrast was inside the introducer sheath with the embolization coil.During functional analysis, the ruby coil could not be advanced into the lantern due to dried contrast inside the hub.Conclusions: evaluation of the returned devices revealed that the stretch resistant (sr) wire of the first ruby coil evaluated was fractured.This type of damage likely occurred due to forceful retraction against resistance while re-sheathing the coil.Dried contrast on the embolization coil, inside the introducer sheath, or in the hub of the lantern may have contributed to this resistance and the unintentional detachment.Evaluation of the second returned ruby coil revealed that the pusher assembly was kinked and contrast was inside the introducer sheath with the embolization coil.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned device revealed that the introducer sheath had contrast inside.The root cause of the contrast found inside the introducer sheath could not be determined; however, the contrast inside the introducer sheath prevented the ruby coil from being advanced into the lantern during the functional analysis.Evaluation of the returned lantern revealed that it was kinked and the lumen had contrast inside.The kink likely occurred due to physician handling during insertion of a ruby coil, as was mentioned in the complaint.The kink in the lantern likely caused the resistance experienced while attempting to advance a new ruby coil into it.The root cause of the contrast inside the lumen of the lantern 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: 1.3005168196-2017-01677.2.3005168196-2017-01679.
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Event Description
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The patient was undergoing a coil embolization procedure to treat an endoleak using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully deployed and detached a ruby coil into the target vessel using the lantern.The physician then selected another branch and attempted to advance a new ruby coil; however, the lantern moved so the physician decided to withdraw the ruby coil and use his non-penumbra guidewire to select the branch again.Upon re-sheathing the ruby coil, resistance was encountered and the ruby coil unintentionally detached as the physician was bringing back the last portion of the coil into the introducer sheath.The physician then pulled back the introducer sheath and the detached coil came out of the lantern.The physician asked his scrub technologist to make sure her gloves did not have contrast on them because he felt that the ruby coil pusher assembly was sticky and her gloves were full of contrast.The physician then chose another ruby coil and successfully deployed and detached it in the selected portion of the endoleak.After that, the physician tracked the lantern through the superior mesenteric artery (sma) to the inferior mesenteric artery (ima) to select another portion of the endoleak and successfully placed several more coils.Next, the physician accidentally kinked the lantern a few inches from the hub.While attempting to advance a new ruby coil through the kinked lantern, the physician experienced resistance and was unable to advance the coil through.Subsequently, the pusher assembly became bent.Therefore, the ruby coil was removed and the procedure was successfully completed using additional coils and the same lantern.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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