MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD #2 LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia, cied system/pocket infection, and lead fracture.Spectranetics lld #2 lead locking devices (lld #2s) were inserted into each lead, to provide traction.In addition, medtronic polysorb suture was tied to the lead insulation, to provide additional traction.Approximately 10 attempts were made to retract the rv lead distal screw from the heart but were unsuccessful.There were no attempts to retract the ra lead distal screw, because of noted lead fracture.Beginning with a spectranetics 14f glidelight laser sheath and a spectranetics medium visisheath dilator sheath, minimal resistance was encountered, and advancement was achieved to the rv lead distal end.Using gentle traction/countertraction, the rv lead immediately came free, and the glidelight, visisheath, and rv lead were removed.While the rv lead was being removed from the glidelight outside the patient, a pericardial effusion was noted via transthoracic echocardiography (tte).The effusion rapidly grew, and the patient's blood pressure dropped.Rescue efforts began immediately, including pericardiocentesis and sternotomy, and a small rv perforation was discovered and repaired.After the repair, the ra lead was extracted with use of the same 14f glidelight.The patient survived the procedure.This report captures the lld #2 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.
Additional Manufacturer Narrative
A4): patient weight unknown h3): the lld #2 was not returned, thus no returned product investigation was performed.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 #2 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: 20019631
• Report Number: 3007284006-2024-00179
• Device Sequence Number: 21001333
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)260131(10)FLC24A24A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990713
• 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): 08/20/2024

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: 01/31/2026
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC24A24A
• 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: 08/14/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2024
• 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: ABBOTT 1888TC/46 RA PACING LEAD; ABBOTT 1888TC/52 RV PACING LEAD; MEDTRONIC POLYSORB SUTURE, FOR TRACTION; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD #2 IN RA LEAD; SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White