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Catalog Number RBY4C0835 |
Device Problems
Positioning Failure (1158); Failure to Fold (1255); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/24/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2017-01822.
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Event Description
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The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while attempting to implant two ruby coils in the target vessel, the physician noticed that the coils were not taking their intended shape; therefore, they were removed.The procedure was completed using a non-penumbra coil.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Please note the device is no longer available for return as mentioned in the initial mdr; therefore, the mdr was updated accordingly.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: 3005168196-2017-01822.The hospital discarded the device.
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Search Alerts/Recalls
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