|
Model Number 518-062 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Cardiac Perforation (2513)
|
Event Date 12/29/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
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 device.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.
|
|
Event Description
|
A lead extraction procedure commenced to remove a non functioning right atrial (ra) lead.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.The physician began the extraction by using a spectranetics 12f glidelight laser sheath and a spectranetics small visisheath dilator sheath.He was able to advance through binding that was present in the subclavian innominate junction, when the lead''s tip released.The lead pulled back into the glidelight, and the glidelight jumped forward toward the superior vena cava''s (svc''s) lateral wall.The patient''s blood pressure dropped and the physician was concerned an svc perforation had occurred.Rescue efforts began immediately, including rescue balloon and sternotomy.A small 1 cm perforation was discovered in the ra apex, successfully repaired, and the patient survived the procedure.This event captures the lld providing traction to the ra lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
|
|
Search Alerts/Recalls
|
|
|