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 12/14/2023

Event Type  Injury  

Manufacturer Narrative

D4): device lot, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.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.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function/lead failure.Two abandoned rv leads were present in the patient as well, with a plan to extract them if the initial procedure went smoothly.A spectranetics lld ez lead locking device (lld ez) was inserted into the rv lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on the rv lead, progress stalled so efforts switched to the ra lead.An lld ez was inserted into the ra lead, and the 14f glidelight (along with the glidelight''s teflon outer sheath) was used to advance to the superior vena cava (svc).A spectranetics 11f tightrail mini rotating dilator sheath was used next to progress down to the ra lead''s ring electrode, and when no further advancement was made, additional traction was applied via the lld.Upsizing to a 13f tightrail rotating dilator sheath to get over the ring electrode, the ra lead came free, but the patient''s blood pressure dropped.Rescue efforts began immediately, including rescue balloon, chest compressions, and sternotomy.Blood was removed from the chest via suction, and a 1.5-2 cm perforation was discovered in the ra and repaired.After repair, the remaining 3 leads were removed through the ra, and it was noted that the leads were adhered to the tricuspid valve (tv); therefore, the tv was replaced at that time.The patient survived the procedure.This report captures the lld ez providing traction to the ra lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 18455496
• MDR Text Key: 332203976
• Report Number: 3007284006-2024-00002
• Device Sequence Number: 1
• Product Code: DRB
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: ABBOTT 1488TC RV PACING LEAD.; MEDTRONIC 4012 ABANDONED RV PACING LEAD.; MEDTRONIC 4524 RA PACING LEAD.; MEDTRONIC 5013 ABANDONED RV PACING LEAD.; SPECTRANETICS 11F TIGHTRAIL MINI DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LLD EZ IN RV LEAD.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White