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Catalog Number 400SMTSTD0930 |
Device Problem
Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/22/2017 |
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.This report is associated with mfr report numbers: 3005168196-2017-02247, 3005168196-2017-02249, 3005168196-2017-02250.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 ascending aorta using penumbra smart coils (smart coils).During the procedure, the physician successfully deployed and detached five smart coils using a non-penumbra microcatheter, but also felt resistance advancing four smart coils out of the microcatheter and into the patient.It was reported that the physician was having difficulty seeing when the smart coils exited the microcatheter, and therefore the physician was unsure whether the resistance was caused by the microcatheter positioning, a possible kink in the microcatheter, or whether the resistance was due to the smart coils.The four smart coils were therefore retracted, and the procedure was continued using shorter smart coils.The procedure was then completed using a lantern delivery microcatheter and ruby coils.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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