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 03/20/2024

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to need for mri compatibility.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath and a spectranetics visisheath dilator sheath, both the ra and rv leads were extracted.After removal of the rv lead, an effusion was noted via transesophageal echocardiography (tee).Rescue efforts began immediately, including rescue balloon and sternotomy.An rv perforation was discovered and repaired, and the patient survived the procedure.This report captures the lld ez providing traction within the rv lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

A2): patient''s date of birth, age unk.A4): patient''s weight unk.B7): other relevant history unk.D4): device lot number, 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.

• 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: 19090138
• MDR Text Key: 339945817
• Report Number: 3007284006-2024-00075
• 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: 04/11/2024

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: 04/11/2024
• 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: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ IN RA LEAD; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White