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Model Number SCH1 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2021 |
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.This report is associated with mfr report number: 3005168196-2021-02661.
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Event Description
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The patient was undergoing a coil embolization procedure in the vertebral artery using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a non-penumbra catheter.During the procedure, the physician placed and detached four smart coils using the handle and two non-penumbra coils in the target vessel.After advancing another smart coil into the target location, the handle failed to detach the coil after several attempts.Therefore, the smart coil and the handle were removed.The procedure was completed using three other coils, the same microcatheter and the same catheter.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Evaluation of the returned smart coil could not confirm the reported complaint.Evaluation revealed that the pet lock was separated.This damage likely occurred due to coil detachment attempted during the procedure.Evaluation also revealed that the pusher assembly was fractured and ovalized, the pull wire was retracted from the pusher assembly ddt, the embolization coil was detached from the pusher assembly and had offset coil winds.This damage was incidental to the reported complaint.Based on the returned condition, the root cause of the reported complaint could not be determined.Evaluation of the returned handle could not confirm the reported complaint.Evaluation revealed that the handle was functional and undamaged.During functional testing, the handle was tested with a handle test fixture and performed within specification.The handle was able to detach a demonstration smart coil without issue.Penumbra coils and handles 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.This report is associated with mfr report number: 1.3005168196-2021-02661.
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Search Alerts/Recalls
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