H3): the device was discarded, thus no investigation could be completed.H6): 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 single lumen right ventricular (rv) lead, and a triple lumen rv lead, due to non-function.To provide traction, a spectranetics lld e lead locking device (lld e) was inserted into the single lumen lead, and three spectranetics lld ez lead locking devices (lld ezs) were inserted into the triple lumen lead.Beginning with a spectranetics 13f tightrail sub-c rotating dilator sheath on the single lumen lead, advancement was made to the innominate/superior vena cava (svc) junction.Next, a spectranetics 16f glidelight laser sheath was used, progressing into the heart, then advancing without lasing to the lead''s tip.Light traction was applied by the lld e, and the lead tip came free.The glidelight was pulled back near the inferior vena cava (ivc) region, the lead was removed, and a guide wire was placed to prepare for re-implantation of a new lead.The patient''s blood pressure slowly dropped, but no injury was evident.The glidelight was removed, and at that time, a pericardial effusion was noted via transesophageal echocardiography (tee).Rescue efforts began, including rescue balloon and sternotomy.A small, anterior wall rv perforation was discovered and repaired, and a new lead was implanted.The decision was made to abandon the extraction attempt of the triple lumen lead.Attempts were made to unlock each lld from the lead, but were unsuccessful.The first lumen/lld (mdr #3007284006-2024-00010), the second lumen/lld (mdr #3007284006-2024-00011), and the third lumen/lld (mdr #3007284006-2024-00012) were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld e providing traction within the single lumen lead when the perforation occurred, requiring intervention.There was no alleged malfunction of the lld e in use during the procedure.
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