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Catalog Number RBYPODJ30 |
Device Problems
Bent (1059); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2017-01812.The hospital disposed of the device.
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Event Description
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The patient was undergoing a coil embolization procedure using pod packing coils (podjs) and ruby coils.During the procedure, the physician felt resistance while attempting to advance a podj through its introducer sheath on the back table and found that the pusher wire had become kinked.The podj was therefore not used in the procedure.The physician then felt strong resistance while attempting to advance a ruby coil through a non-penumbra microcatheter and therefore, the ruby coil was removed.Upon removal, the physician found that the pusher wire of the ruby coil was kinked.The procedure was then completed using the same microcatheter and additional podjs and ruby coils.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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