Patient's date of birth unk.Patient's weight unk.Relevant tests/laboratory data unk.Other relevant history unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.Cardiac perforation is a known risk of complication with use of the lld.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
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A lead extraction procedure commenced to remove a capped right ventricular (rv) and an active rv lead, along with a right atrial (ra) lead due to device infection and sepsis.Spectranetics lead locking devices (llds) and suture were used to provide traction.Multiple spectranetics devices (14f glidelight laser sheath, 11f tightrail sub-c rotating dilator sheath, 11f tightrail (long)) were used to successfully remove the ra lead, accomplished only after changing from lead to lead multiple times due to heavy scarring.Once the ra lead was successfully removed, the capped rv lead was targeted next due to the active rv lead having been stretched with insulation damage.Progress stalled in the superior vena cava (svc) with use of multiple devices, so the physician upsized to a 16f glidelight because the lead appeared to be snowplowing (bunching up on itself).Advancement was made through the svc, into the ra, and then into the rv.The physician monitored the patient''s blood pressure, vital signs, and transesophageal echocardiography (tee) with no evidence of injury.He proceeded further into the rv with the 16f glidelight and was still a few centimeters away from the tip of the lead when the rv lead tip pulled back abruptly with use of traction.Approximately 30 seconds after the lead and glidelight were removed, the patient''s blood pressure dropped.A pericardial effusion was detected via tee.Rescue efforts began immediately, including rescue balloon, pump and sternotomy.An rv apex perforation was discovered and repaired successfully.The active rv lead was removed post-sternotomy by creating a small opening in the patient''s ra and removing the rv lead using purse string sutures.The heart was sutured, the chest was closed, and the patient survived the procedure.This report captures the lld providing traction when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
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