MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD E LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-039
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	05/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b): patient's gender unk.H3): the device was discarded, thus no investigation could be completed.H6): perforation of vessels 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 or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv), a right atrial (ra), and a left ventricular (lv) lead due to bacteremia.Prior to the procedure, the patient had a small vegetation suspected on the rv lead near the tricuspid valve.A temporary pacemaker was placed, and spectranetics lead locking devices (lld e in lv lead, lld #2s in rv and ra leads) were inserted into each lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath on the lv lead, advancement was made to just proximal of the superior vena cava (svc)/ra junction.Traction was applied to the lv lead, the lead was pulled into the glidelight, and both were removed, but the patient's blood pressure dropped.Rescue efforts began immediately, including rescue balloon.Transesophageal echocardiography (tee) detected no effusion in the svc or innominate regions.However, an effusion was noted, suspecting a small perforation of a lateral branch of the coronary sinus.A subxiphoid window was performed, suction was applied, and a blake drain was placed, withdrawing 300 ml of blood.The patient stabilized and the extraction continued.A 16f glidelight was used on the rv lead, and the lead was successfully extracted.Then, using a 14f glidelight and switching to a 16f glidelight on the ra lead, the lead was extracted as well, with no issues.The patient survived the procedure.This report captures the lld e providing traction to the lv lead when the suspected perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: LLD E LEAD LOCKING DEVICE
• Common Device Name: 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 ; 719447-2465
• MDR Report Key: 19575698
• Report Number: 3007284006-2024-00126
• Device Sequence Number: 14439084
• Product Code: DRB
• UDI-Device Identifier: 00813132023058
• UDI-Public: (01)00813132023058(17)250110(10)FLJ23A10A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2025
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: FLJ23A10A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC 0158 RV PACING LEAD; BOSTON SCIENTIFIC 4088 RA PACING LEAD; MEDTRONIC 4193 LV LEAD; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD #2 LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 134 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White