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Model Number 83777 |
Device Problems
Premature Activation (1484); Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the pusher wire and the coil were returned.The pusher wire was inspected and it was kinked the main coil was inspected and it was kinked/stretched.Microscopic inspection revealed the proximal end of the pusher wire has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Inspection of the main coil revealed the zap tip has a smooth surface and the interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the main coil revealed that the zap tip overall dimension (od) and the primary coil matches the specification while the number of fiber bundles do not match the specification.The fiber loss were out of specification due to the coil condition.For the pusher wire, the distal solder (od), mid solder (od), distal tfe (od) and proximal tfe (od) all matches the specification.
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Event Description
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Reportable based on device analysis completed on 28sep2020.It was reported that the coil deployed prematurely.The target lesion area was located in the coronary artery.A 2/6mm x 8 cm interlock embolic was selected for use in a congenital coronary arteriovenous fistula.During the procedure, the coil was pushed into the microcatheter and the deployment was not suitable.The guidewire and coil was retrieved, but the coil was not found.Lately, it was noted that the coil deployed inside the microcatheter and the interlocking detachable arms were damaged.The coil was simply pulled out with the catheter.The procedure was completed with another of the same device.No patient complications reported.However, device investigation revealed missing fiber bundles.
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Search Alerts/Recalls
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