It was reported the patient presented for implant procedure.During surgery, it was noted the stylet required excessive force to separate from the left ventricular lead, the inner conductor came loose, and the stylet was kinked.The procedure was completed using a different lead.There were no patient consequences.
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A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The reported events are stylet could not be removed, ¿inner conductor came loose¿ and stylet was kinked.As received, a complete lead was returned in one piece with the stylet stuck inside the lead.The reported events of stylet could not be removed and ¿inner conductor came loose¿ were confirmed.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 insulation stylet coating was bunched up/clogged with the inner coil distal to the connector pin.The cause of the reported events was due to bunched up insulation coating of the stylet that prevented the removal of the stylet and excessive forces resulted in the connector pin and cap to be pulled out of the connector assembly.Unable to fully evaluate the stylet due to stuck inside the lead and damaged due to procedure.
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