The reported event of stylet could not be removed was confirmed.As received, a complete lead was returned in one piece with the stylet stuck inside the lead.Visual inspection of the lead found that the connector pin and connector cap were pulled out of the connector assembly along with the inner coil which is consistent with procedural damage and the ptfe stylet coating was bunched up/clogged distal to the connector pin.The cause of the reported event was due to bunched up ptfe coating of the stylet that prevented the removal of the guidewire and excessive forces resulted in the connector pin and cap to be pulled out of the connector assembly.A review of the device history record (dhr) confirmed that no issues were identified related to this reported event.
|