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

Model Number 518-062

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/06/2023

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv), and a left ventricular (lv) lead due to bacteremia.Based on ct imaging, a previously placed stent near the entry site appeared to have tacked the leads to the vessel wall.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.To determine whether the leads had been tacked, each lead was manually pulled, and appeared free.Beginning with a spectranetics 14f glidelight laser sheath on the rv lead, the rv lead was removed without issue.However, when the glidelight was removed from the patient, uncontrolled bleeding was noted from the subclavian region.Interventions began immediately, including blood transfusions and successful repair of what was likely an extension of the perforation at the access site within the subclavian vein (mdr #3007284006-2023-00052).The decision was made not to remove the lv and ra leads, due to the amount of blood loss and the concern that the perforation would extend again.The physician attempted to unlock both llds from the lv and ra leads, but was unsuccessful.The lv lead/lld (mdr #3007284006-2023-00053) and the ra lead/lld (mdr #3007284006-2023-00054) were cut and capped and remained in the patient.The patient survived the procedure, with the plan to bring the patient back at a later date to attempt femoral snaring of the leads.This report captures the lld within the ra lead which was cut and capped and remained in the patient.

Manufacturer Narrative

A4): patient''s weight unk.H3): a portion of the lld was discarded, and a portion remained within the ra lead in the patient, thus no investigation could be completed.H6): lld cut/cap 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.

• 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: 18058069
• MDR Text Key: 327248083
• Report Number: 3007284006-2023-00054
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)250823(10)FLP23H22A
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• 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
• Device Lot Number: FLP23H22A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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: BOSTON SCIENTIFIC 0672 RV ICD LEAD.; BOSTON SCIENTIFIC 4674 LV LEAD.; BOSTON SCIENTIFIC 7741 RA PACING LEAD.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES.
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American