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Catalog Number RBYPODJ45 |
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 08/17/2022 |
Event Type
malfunction
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Event Description
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The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).It should be noted that the patient's anatomy was tortuous and calcified.During the procedure, the physician successfully implanted two pod pcs into the target location.When the next pod pc was advanced approximately fifty centimeters into the vessel, resistance was encountered.The physician attempted to retract the pod pc pusher wire and noticed that the coil was unintentionally detached.The pusher wire was removed from the lantern and a syringe was used to flush the pod pc into the target location.Upon removal, the pod pc pusher wire was broken approximately two centimeters from the detachment zone.It was reported that the coil and a piece of the distal tip of the pusher wire were implanted; however, imaging of the target site did not confirm this.No attempts were made to remove the piece of the pusher wire.At this point, the procedure was successfully completed.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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