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Catalog Number RBY2C1260 |
Device Problems
Bent (1059); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/10/2017 |
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: 3005168196-2017-00709.The hospital disposed of the device.
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Event Description
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The patient was undergoing a coil embolization procedure treating a fistula using ruby coils.During the procedure, the physician successfully deployed and detached four ruby coils in the fistula using a lantern delivery microcatheter (lantern).Upon attempting to advance a new ruby coil into the lantern, the hospital technician inadvertently bent the ruby coil pusher assembly; therefore it was removed.The physician then successfully deployed and detached additional coils.Upon attempting to advance another ruby coil through the lantern, the physician experienced resistance and the ruby coil was unable to advance past the friction lock of the introducer sheath; therefore, it was removed.The procedure was completed using the same lantern and additional ruby coils.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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