Catalog Number CAT8XTORQ115 |
Device Problem
Device Fell (4014)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.The reported complaint involves the sterility of a dropped device prior to use in the patient.Sterility of a dropped device cannot be confirmed in the evaluation lab and does not involve manufacturing records; therefore, an investigation will not be performed.
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Event Description
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During preparation for a medical procedure using an indigo system aspiration catheter 8 (cat8), the cat8 was accidentally dropped on the floor and became unsterile.The cat8 was therefore not used in the procedure.The procedure was completed using a new cat8.
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Search Alerts/Recalls
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