Model Number 518-062 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 11/29/2021 |
Event Type
Injury
|
Event Description
|
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia and removal of an abandoned pacemaker system.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician attempted removal of the ra lead by using a spectranetics 11f tightrail sub-c rotating dilator sheath.Upon attempting removal of the lead from the device, the tightrail became stuck.It was noted that there was a piece of calcium stuck at the tip of the tightrail.The ra lead was cut and the tightrail was removed (mdr #1721279-2021-00245).The physician was unable to unlock the lld from the ra lead since it had been cut, and both the ra lead with the lld inside were cut and capped and remained in the patient.The physician then attempted to unlock the lld from the rv lead but was unsuccessful, so the rv lead with the lld inside were cut and capped and remained in the patient (mdr #1721279-2021-00247).There was no reported patient harm.This report captures the lld which was cut and capped within the ra lead and remained in the patient.Although there was no alleged malfunction of the lld during the procedure, this is also being reported for product problem since a portion of the lld remained in the patient.
|
|
Manufacturer Narrative
|
Patient''s weight unk.Patient''s ethnicity/race unk.Other relevant history unk.A portion of the device remained in the patient and the remnant was discarded, thus no investigation could be completed.
|
|
Manufacturer Narrative
|
Patient''s weight unk.Patient''s ethnicity/race unk.Other relevant history unk.A portion of the device remained in the patient and the remnant was discarded, thus no investigation could be completed.
|
|
Event Description
|
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia and removal of an abandoned pacemaker system.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician attempted removal of the ra lead by using a spectranetics 11f tightrail sub-c rotating dilator sheath.Upon attempting removal of the lead from the device, the tightrail became stuck.It was noted that there was a piece of calcium stuck at the tip of the tightrail.The ra lead was cut and the tightrail was removed (mdr #1721279-2021-00245).The physician was unable to unlock the lld from the ra lead since it had been cut, and both the ra lead with the lld inside were cut and capped and remained in the patient.The physician then attempted to unlock the lld from the rv lead but was unsuccessful, so the rv lead with the lld inside were cut and capped and remained in the patient (mdr #1721279-2021-00247).There was no reported patient harm.This report captures the lld which was cut and capped within the ra lead and remained in the patient.Although there was no alleged malfunction of the lld during the procedure, this is also being reported for product problem since a portion of the lld remained in the patient.
|
|
Search Alerts/Recalls
|