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Catalog Number RBY2C0630 |
Device Problems
Kinked (1339); Device Damaged Prior to Use (2284); Device Handling Problem (3265)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.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: 3005168196-2018-00769.The hospital disposed of the device.
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Event Description
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The patient was undergoing a coil embolization procedure in the hepatic artery using ruby coils.During the procedure, the hospital technician inadvertently kinked the pusher assembly of a ruby coil while removing it from the packaging.The damage to the ruby coil occurred prior to use, and therefore it was not used in the procedure.The technician then accidently caused another ruby coil to fall off of the back table and on to the floor later in the procedure.The ruby coil became contaminated prior to use, and therefore it was not used in the procedure.The procedure was completed using new ruby coils.
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Search Alerts/Recalls
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