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Catalog Number RBY2C0630 |
Device Problems
Failure to Advance (2524); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/20/2017 |
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: 3005168196-2017-02263.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 splenic artery using ruby coils.During the procedure, while attempting to advance two ruby coils through the non-penumbra microcatheter, the physician did not mention feeling any resistance; however, the coils became stuck and were unable to advance out of the microcatheter.Therefore, the ruby coils were removed and the procedure was then completed using new ruby coils 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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