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Catalog Number 4004C1030 |
Device Problems
Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2017 |
Event Type
malfunction
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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.The hospital disposed of the device.
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Event Description
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The patient was undergoing a coil embolization procedure in the left subclavian artery using penumbra coils 400s (pc400s).During the procedure, the physician placed two non-penumbra coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a pc400 through the microcatheter, the physician experienced resistance after advancing the pc400 half way through the microcatheter.Subsequently, the pc400 became stuck when it was about to exit the tip of the microcatheter; therefore, microcatheter and pc400 were removed altogether.The procedure was completed using the same microcatheter and four additional pc400s without further issues.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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