Model Number BC0210M |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2024 |
Event Type
Injury
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Manufacturer Narrative
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A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The reported issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
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Event Description
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It was reported that to treat a dura fistula, a scepter mini should be used in combination with squid liquid embolic.The preparation of the scepter went well.The squid could not be injected through the scepter.A little came out with greater pressure, but then no more.The treatment was stopped and postponed.Patient is doing well.
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Manufacturer Narrative
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Investigation conclusion: the investigation of the returned scepter mini found the guidewire port of the hub and distal end of the guidewire lumen occluded with material consistent with solidified squid liquid embolic.As squid was observed at the distal end of the device, the liquid embolic was able to be injected through the lumen; however, solidified squid occluding the guidewire lumen port of the hub and guidewire lumen is consistent with the catheter lumen not being coated correctly with dmso per the ifu.This condition causes the squid to react with the saline used to hydrate the device during preparation and solidify.
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Event Description
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Please see section h10 for device investigation.
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Search Alerts/Recalls
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