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Model Number RBY2C2860-B |
Device Problems
Break (1069); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2021 |
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.
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Event Description
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The patient was undergoing a coil embolization procedure in the aorta using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a ruby coil to the target vessel; however, the physician determined the ruby coil was too large.Therefore, the ruby coil was removed and saved for later use.Later in the procedure, while attempting to re-advance the previously removed ruby coil into the microcatheter, the physician experienced resistance, and subsequently, the ruby coil detached from its pusher assembly within its introducer sheath prior to entering the microcatheter.Therefore, the ruby coil was removed.The procedure was completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, 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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Search Alerts/Recalls
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