Catalog Number 400SMTSFT3H06 |
Device Problems
Looping (1370); Failure to Advance (2524); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/20/2017 |
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.
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Event Description
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The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician tested the smart coil in a tray of saline before attempting to advance it into the hub of the non-penumbra microcatheter.The physician then felt resistance after the smart coil formed a loop while advancing out of the tip of the introducer sheath and into the hub of the non-penumbra microcatheter, and therefore the smart coil was removed.The procedure was then completed using a new smart coil and additional coils with the same microcatheter.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned device revealed that the penumbra smart coil (smart coil) pusher assembly was kinked.These kinks were likely incidental and may have occurred from packaging the device for return to penumbra.The smart coil was attempted to be advanced through a demonstration microcatheter.While advancing the smart coil through the demonstration microcatheter, resistance was encountered as the kinks in the pusher assembly were being advanced through the microcatheter.However, the smart coil was able to be advanced completely through the microcatheter and out of the distal tip with the experienced resistance.The root cause of the reported resistance felt during the procedure and the reported looping of the smart coil could not be determined.The non-penumbra microcatheter referred to in the complaint was not returned for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra catheters and coils are inspected during in-process inspection and during quality inspection after manufacturing.
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Search Alerts/Recalls
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