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 Device Embedded In Tissue or Plaque (3165)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

B7): other relevant history unk.D4): device lot number, expiration date unk.Partial udi populated.H3): a portion of the device was discarded and a portion of the device remained in the patient, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): although lld cut/cap is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the rv lead prior to cutting and capping.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 two right ventricular (rv, models 7120q and 6931) leads due to non-function.Spectranetics lld ez lead locking devices (lld ezs) were inserted into both leads to provide traction.Beginning with a spectranetics 16f glidelight laser sheath on the 7120q lead, progress was made through the innominate with ease.Before entering the superior vena cava (svc) region, surgical backup was requested and confirmed, and the procedure continued.Advancement continued down the svc, through the svc/ra junction, where significant lead on lead binding was encountered.While the glidelight was in the ra, an effusion was detected via echo imaging.Rescue efforts began, including rescue balloon, pericardiocentesis, and sternotomy, since the echo revealed large amounts of blood.A 2-3 inch svc lateral wall perforation was discovered (mdr #3007284006-2024-00048).The repair of the svc perforation proved to be difficult, but was completed using pericardium tissue.Another perforation was discovered in the innominate region, and the innominate vein was ligated.At that time, the decision was made to abandon the two rv leads.There was no attempt to unlock the llds from the leads, so 7120q rv lead/lld (mdr #3007284006-2024-00049) and 6931 rv lead/lld were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld ez within the 6931 rv lead, which was cut and capped and remained in the patient.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: 18867590
• MDR Text Key: 337241946
• Report Number: 3007284006-2024-00050
• 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
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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
• 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 7120Q RV ICD LEAD; MEDTRONIC 6931 RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ IN 7120Q RV ICD LEAD
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American