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 Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 07/13/2023

Event Type  Death  

Manufacturer Narrative

A4): patient's weight unk.B6): relevant tests/laboratory data unk.D4): device lot number, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be performed.H4): device manufacture date unk because lot number unk h6): 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 right atrial (ra), a right ventricular (rv), and a left ventricular (lv) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Attempting to remove the rv lead first, a spectranetics 14f glidelight laser sheath was advanced to the innominate region, where progress stalled.A 16f glidelight was used next, and successfully progressed down the superior vena cava (svc) and into the right atrium.At the area of the tricuspid valve, the rv lead abruptly sprung back and the patient''s blood pressure dropped.An rv apex perforation was suspected.The 16f glidelight was removed from the patient and a pericardiocentesis was performed; however, it was determined that the blood in the pericardial sac was clotting.Cpr was performed but was unsuccessful and the patient died.It was determined pre-procedure that the patient was too sick to be a surgical candidate, and an extensive discussion occurred with the patient and family that if anything were to happen, that there was nothing the physician could do.This report captures the lld providing traction to the rv lead when the suspected perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

D1): brand name corrected to lld ez lead locking device (from lead locking device) to align with brand name for the model number.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: 17459971
• MDR Text Key: 320402175
• Report Number: 3007284006-2023-00006
• 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,Followup
• Report Date: 08/08/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/08/2023
• 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: BOSTON SCIENTIFIC 4470 RA PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1458Q LV LEAD; ST. JUDE MEDICAL 7122Q RV ICD LEAD
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White