Device Problems
Device Damaged Prior to Use (2284); Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/21/2018 |
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2018-02109.
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Event Description
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During preparation for a medical procedure, a hospital staff noticed that the distal ends of two indigo system aspiration catheter 6¿s (cat6's) were kinked upon removal from the packaging.It was also noted that the cat6¿s would not flush properly.The damage to the cat6's were found prior to use, therefore, the cat6¿s were not used in the procedure.The procedure was completed using a new cat6.
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Manufacturer Narrative
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This report is associated with mfr report number: 3005168196-2018-02109.
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Event Description
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During preparation for a medical procedure, a hospital staff member noticed that the distal ends of an indigo system cat5 aspiration catheter (cat5) and an indigo system aspiration catheter 6 (cat6) were kinked upon removal from the packaging.It was also noted that the cat5 and cat6 would not flush properly.The damage to the devices were found prior to use, therefore, the devices were not used in the procedure.The procedure was completed using a new cat6.
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Search Alerts/Recalls
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