Model Number 26924 |
Device Problems
Premature Activation (1484); Difficult to Advance (2920)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/17/2020 |
Event Type
malfunction
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Event Description
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It was reported that the stent was difficult to track over the wire and inadvertently deployed.A 6 x 60 x 130 innova self-expanding stent was selected for a procedure.Upon inserting the stent delivery system over the.014 wire, it was difficult to track over the wire.Prior to entering the sheath, the physician noticed the stent had flowered out.The procedure was completed successfully with a new 6 x 60 innova device and patient was reported as fine post procedure.
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Manufacturer Narrative
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Device analysis by mfr: the returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is partially deployed 1.5cm from the distal end of the middle sheath.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The yellow thumbwheel lock is missing.Inspection of the remainder of the device, revealed no other damage or irregularities.
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Event Description
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It was reported that the stent was difficult to track over the wire and inadvertently deployed.A 6x60x130 innova self-expanding stent was selected for a procedure.Upon inserting the stent delivery system over the.014 wire, it was difficult to track.Prior to entering the sheath, the physician noticed the stent had flowered out.The procedure was completed successfully with a new 6x60 innova device and patient was reported as fine post procedure.
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Search Alerts/Recalls
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