Model Number 83735 |
Device Problems
Entrapment of Device (1212); Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that the coil protruded from catheter tip upon removal.The target lesion was located in the severely tortuous and non-calcified celiac artery.A 12mm x 20cm idc-18 coil was selected for use.During the procedure, it was noted that the coil detached early within the distal part of the catheter (the main coil and the arm of the delivery wire were separated).Also, it was found under fluoroscopy that the locking arm part got stuck.The coil was removed together with the catheter and protruded from the tip.The procedure was completed with another of the same device.No patient complications reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: only the main coil was returned for product analysis.Visual inspection revealed that the mail coil was found stretched and kinked.Since only the main coil returned the functional inspection could not be performed.For dimensional inspection of the main coil, the zap tip and primary coil outer diameter were within specification.
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Event Description
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It was reported that the coil protruded from catheter tip upon removal.The target lesion was located in the severely tortuous and non-calcified celiac artery.A 12mm x 20cm idc-18 coil was selected for use.During the procedure, it was noted that the coil detached early within the distal part of the catheter (the main coil and the arm of the delivery wire were separated).Also, it was found under fluoroscopy that the locking arm part got stuck.The coil was removed together with the catheter and protruded from the tip.The procedure was completed with another of the same device.No patient complications reported.
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Search Alerts/Recalls
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