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Catalog Number RBYPODJ30 |
Device Problems
Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Results: the pusher assembly was kinked approximately 11.0 cm from the proximal end where the wire enters the packaging hoop.There was minor bends on the length of the podj pusher assembly.Conclusions: evaluation of the returned podj revealed a kink on its proximal end where the wire enters the packaging hoop.This damage was likely a result of retracting the device from the hoop at extreme angles.Further evaluation revealed minor bends on the length of the catheter.This damage was likely incidental and occurred during packaging for return to penumbra.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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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During preparation for a coil embolization procedure, the hospital technician inadvertently kinked the pusher assembly of the pod packing coil (podj) upon removal from the packaging.The damage to the podj was found prior to use.Therefore, the podj was not used in the procedure.The procedure was completed using new ruby and pod packing coils.
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Search Alerts/Recalls
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