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 Problems Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 08/21/2023

Event Type  Death  

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 cied system/pocket infection.Various models of spectranetics lead locking devices (llds) (lld ez in ra and lv leads, lld #2 in rv lead) were inserted into each lead, and suture was used as well, to provide traction.When using a spectranetics 12f glidelight laser sheath to attempt extraction of the ra lead, resistance was met.A 14f glidelight was used next to attempt extraction of the rv lead, but progress stalled.The 14f glidelight was then used on the ra lead, and the lead was successfully removed.Attempts were made again to extract the rv lead with the 14f glidelight, but were unsuccessful.Then, a spectranetics 11f tightrail rotating dilator sheath was used on the rv lead, and the lead was successfully removed.Lastly, attempting to remove the lv lead, the 12f glidelight was used but progress stalled.Upsizing to the 14f glidelight, the lv lead was removed.After removal, a pericardial effusion was detected and the patient''s blood pressure dropped.Rescue efforts began, including bypass and sternotomy.Perforations to the coronary sinus (cs) and cs os (opening from the ra into the cs) were detected.Despite extensive rescue efforts, the patient did not survive.The physician noted the lv lead insulation was compromised, and the insulation likely perforated the cs and cs os as the lead was being removed with traction from the lld, since the glidelight did not lase near the region.This report captures the lld providing traction within the lv lead when the perforations occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H6): perforation of vessels and death are known risks 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: 17741233
• MDR Text Key: 323349089
• Report Number: 3007284006-2023-00025
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)250103(10)FLP22M20A
• 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: 09/13/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP22M20A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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: ABBOTT 1458Q LV LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD #2 IN RV LEAD; SPECTRANETICS LLD EZ IN RA LEAD; ST. JUDE MEDICAL 2088 RA PACING LEAD; ST. JUDE MEDICAL 7120Q RV ICD LEAD
• Patient Outcome(s): Required Intervention; Death; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White