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Catalog Number RBYPODJ60 |
Device Problem
Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The patient was undergoing a coil embolization procedure using a packing coil and a non-penumbra catheter.During the procedure, the physician attempted to retract the packing coil.However, the packing coil was unable to retract back into the catheter.It was reported that the packing coil unintentionally detached.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.The exact date of event is unknown.
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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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