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Model Number 83779 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2021 |
Event Type
malfunction
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Event Description
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Reportable based on device analysis completed on 09nov2021.It was reported that the coil was stuck.The target lesion was located in the splenic artery.A 10mm x 50cm interlock was selected for use for the embolization procedure.During the procedure, it was noted that the coil got stuck in the delivery microcatheter (.028 inner diameter).The procedure was completed with a non-bsc coil.No patient complications were reported.However, device analysis revealed that the zap tip and interlocking arm were detached, and the fiber bundles were missing.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.A pusher wire, introducer sheath and main coil were returned analysis.The coil and pusher wire arms were not interlocked within the introducer sheath.A significant amount of blood was found inside the introducer sheath.The coil was inspected, and it was found kinked and severely stretched.The pusher wire was inspected, and it was kinked.No more damages were found in the returned device.Microscopic inspection of the pusher wire was performed and observed that the proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Microscopic inspection of the main coil was performed and observed that the zap tip is detached.The interlocking arm was inspected, and it was detached.Dimensional inspection of the pusher wire that could be measured were performed and were within specifications.Dimensional inspection of the main coil that could be measured were performed and observed that the outer diameter (od) of the zap tip and primary coil were within specifications.However, there were lacking coil fiber bundles.12 fiber bundles were present (specification is 20).
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Search Alerts/Recalls
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