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Catalog Number RBY4C0201 |
Device Problems
Kinked (1339); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/14/2018 |
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.
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Event Description
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The patient was undergoing a coil embolization procedure treating a gi bleed using ruby coils.During the procedure, the hospital technician inadvertently kinked the pusher assembly of a ruby coil while advancing the ruby coil quickly into the non-penumbra microcatheter.The ruby coil was therefore removed, and the procedure was completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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