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Catalog Number RBY2C1660 |
Device Problems
Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/05/2018 |
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 numbers: 3005168196-2018-00929, 3005168196-2018-00930.
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Event Description
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The patient was undergoing a coil embolization procedure to treat a superficial femoral artery (sfa) arteriovenous malformation (avm) using ruby coils.During the procedure, prior to use, a ruby coil was dropped on the floor while being handed to the scrub technologist by the nurse.Therefore, the ruby coil was set aside and a new ruby coil was opened.While attempting to advance the new ruby coil into a lantern delivery microcatheter (lantern), the scrub technologist inadvertently kinked the ruby coil pusher assembly; therefore, it was removed.While removing another ruby coil from the dispenser hoop, the scrub technologist inadvertently kinked the ruby coil pusher assembly.The procedure was completed using another ruby coil 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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