Device evaluated by manufacturer: the device was returned for analysis.A visual inspection of the device revealed that a delivery wire, main coil and introducer sheath were returned for this complaint.The coil and delivery wire arms were not interlocked, the main coil and delivery wire were inside the introducer sheath.The introducer sheath was inspected and no anomalies were noted, the twist lock had been opened.A significant quantity of dried blood was observed inside the introducer sheath.The main coil was found kinked and stretched, besides, the fiber bundles had blood residues.The coil interlocking arm was detached.Functional inspection was performed.The delivery wire was advanced through the introducer sheath, but it was not possible to continue advancing it due to the main coil was stuck; it was necessary to cut the introducer sheath in order to release the main coil.Microscopic inspection of the delivery wire revealed that the proximal end has a smooth surface and the interlocking arm was found in good condition while for the main coil the zap tip has a smooth surface and the interlocking arm was detached.Dimensional inspection of the delivery with the overall dimension (od) of the weld, wire arm and wire zap tip matches with specification.For the main coil, the zap tip (od) and the primary coil (od) matches the specification while the number of distal and proximal fiber bundles did not match the specification.
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Reportable based on device analysis completed on 29 sep 2020.It was reported that the coil prematurely deployed.The target lesion area was located in a moderately tortuous arteriovenous malformation.A 12mm x 20cm interlock-35 was selected for an embolization procedure.During the procedure, it was noted that the coil deployed before reaching the lesion.The coil was removed with the microcatheter.The procedure was completed with a different device.No patient complications were reported.The patient's condition was good post procedure.However, device analysis revealed that the coil interlocking arm was detached and fiber bundles were missing.
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