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Catalog Number RBYLP0204 |
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 08/19/2022 |
Event Type
malfunction
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Event Description
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The patient was undergoing a radioembolization procedure (y90) in the liver using ruby coil lps and a non-penumbra microcatheter.During the procedure, the ruby coil lp would not advance out of its introducer sheath.Therefore, the ruby coil lp was removed.While attempting to use another ruby coil lp, the physician had difficulty advancing the ruby coil lp out of its introducer sheath.Subsequently, while advancing the same ruby coil lp through the microcatheter, the physician and the hospital technologist experienced resistance and the ruby coil lp partially broke in the microcatheter.Therefore, the physician used a hemostat and a syringe and removed the broken ruby coil lp.It was reported that a part of the coil was attached to the pusher assembly.The procedure was completed using non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
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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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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.H3 other text : placeholder.
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Search Alerts/Recalls
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