MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD EZ LEAD LOCKING DEVICE; STYLET, CATHETER

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 02/21/2024

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove 4 leads (two right atrial (ra models 5032(l) and 2088tc(r) and two right ventricular (rv models sct200(l) and 2088tc(r)) to create space for a bi-ventricular upgrade.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Multiple spectranetics devices (16f glidelight laser sheath, tightrail rotating dilator sheath, visisheath dilator sheath) were used during the procedure.Both ra leads and model 2088tc rv lead were extracted successfully.Using the 16f glidelight with traction from the lld ez to attempt removal of the sct200 rv lead, the lead began to fracture.Therefore, further attempts to extract the lead were aborted.There was no attempt to unlock the lld ez from the lead, so the sct200 rv lead/lld were cut and capped and remained in the patient during the procedure, hemodynamic changes were observed but no injury was reported, so the patient was stabilized by anesthesia personnel.Approximately 2 hours post-procedure and during re-implantation of a new lead, the patient''s condition deteriorated.Rescue efforts began, including sternotomy.A 3 cm left innominate perforation was discovered and repaired (mdr #3007284006-2024-00053).Unfortunately, despite rescue efforts, the patient did not survive.The physician believed the innominate perforation occurred during the lead extraction procedure.This report captures the lld within the sct200 rv lead, which was cut and capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

A2): patient''s date of birth unk.A4): patient''s weight unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.D4): device lot number, expiration date unk.Partial udi populated.H3): a portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): although lld cut/cap is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the rv lead prior to cutting and capping.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.

• Brand Name: LLD EZ LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 18861533
• MDR Text Key: 337184719
• Report Number: 3007284006-2024-00054
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDCOR SCT200(L) RV PACING LEAD; MEDTRONIC 5032(L) RA PACING LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL 2088TC(R) RA PACING LEAD; ST. JUDE MEDICAL 2088TC(R) RV PACING LEAD
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White