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 Cardiac Perforation (2513)

Event Date 02/22/2024

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and two right ventricular (rv-one active tined, one abandoned) leads due to cied system/pocket infection.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath on the ra lead, stalled progress was encountered.Next, the same glidelight was used on the abandoned rv lead, alternating between the ra and rv leads until advancement was achieved near the rv lead tip.The abandoned rv lead popped free; however, the patient''s blood pressure immediately dropped.Rescue efforts began, including pericardiocentesis, chest compressions, bypass, and sternotomy.An rv apex perforation was discovered and repaired (mdr #3007284006-2024-00058).It is believed that the lead had been implanted into the apex and had scarred over time.After the repair was complete and the patient had stabilized with an underlying rhythm, the procedure continued with the patient remaining on bypass with the chest open.The same glidelight was used to successfully remove the ra lead.Working to remove the active tined rv lead, a second rv apex perforation occurred when the lead released (mdr #3007284006-2024-00059).Repair to the second perforation was completed immediately, and the patient survived the procedure.This report captures the lld ez within the abandoned rv lead when the first perforation occurred, requiring intervention.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): cardiac perforation 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: 18899382
• MDR Text Key: 337619804
• Report Number: 3007284006-2024-00058
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)250928(10)FLP23J26A
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: FLP23J26A
• 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: 09/26/2023
• 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: ABANDONED RV LEAD MANUFACTURER/TYPE UNK; ACTIVE RV LEAD MANUFACTURER/TYPE UNK; BOSTON SCIENTIFIC 4023 RA PACING LEAD; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White