Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2023
Event Type
malfunction
Event Description
During an implantation procedure, it was not possible to remove the guidewire from the left ventricular (lv) lead, which resulted in damage to the lead.A new lead was successfully implanted to resolved the event.The patient was stable.
Manufacturer Narrative
The reported event of difficulty removing the stylet that resulted in lead damage was confirmed.As received, a complete lead was returned in one piece.Stylet was not returned with the lead.Visual inspection of the lead found that the connector pin and crimp sleeve 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 with the inner coil distal to the connector pin.The cause of the reported event was due to bunched up ptfe coating of the stylet inside the inner coil that prevented the removal of the stylet and excessive forces resulted in the connector pin and crimp sleeve to be pulled out of the connector assembly.