Device Problems
Failure to Advance (2524); Separation Failure (2547)
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2023
Event Type
malfunction
Event Description
During an implant procedure, the guidewire was unable to be removed from or advanced into the left ventricular (lv) lead.A new guidewire was used, but was also unable to be removed or advanced from the lv lead.As a result, the lv lead was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.
Manufacturer Narrative
The reported event of the guidewire getting stuck inside the lead was confirmed.As received, a compete lead with the stuck guidewire was returned in one piece for analysis.The polytetrafluoroethylene (ptfe) coating of the stuck guidewire was found stripped.X-ray and visual examinations found that the inner coil at the connector region was bunched up due to damage caused while attempting to remove the guidewire from the lead.The cause of the reported event was isolated to the bunching of the guidewire ptfe coating inside the inner coil at the connector region that prevented the removal of the guidewire.Electrical testing did not find any indication of conductor fractures or internal shorts.