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 Problems Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

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 Description

A lead extraction procedure commenced to remove a left ventricular (lv) lead due to malfunction.A spectranetics lead locking device (lld ez) was inserted into the lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath, stalled progress was encountered in the mid-subclavian region.A spectranetics 11f tightrail rotating dilator sheath was used next, and steady advancement was achieved and the lead was extracted, with the lead and tightrail being removed together at that time.However, approximately 3 minutes after lead extraction and during the placement of a medtronic lv guide catheter in the coronary sinus (to prepare for lead re-implantation), the patient''s blood pressure dropped.A growing pericardial effusion was noted via transesophageal echocardiography (tee).Rescue efforts began, including a subxiphoid window, and blood was drained from the pericardial space via cell saver.The patient was stable enough that sternotomy nor bypass were required.Re-implantation of the new lv lead was successfully completed, with a chest tube placed for drainage, and the patient survived the procedure.At the time the procedure was completed, no blood loss was occurring; the ct surgeon guessed that the injury was small and tamponaded off when the blood was removed from the pericardial space.This report is being submitted conservatively for the lld ez providing traction within the lv lead when a suspected perforation occurred, requiring intervention.Per philips clinical assessment, it was suspected that a small coronary sinus perforation may have occurred when the lv lead was removed, or during insertion and placement of the lv guide catheter.There was no alleged malfunction of any spectranetics devices 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: 17941658
• MDR Text Key: 325754970
• Report Number: 3007284006-2023-00038
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)250417(10)FLP23D12A
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• 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
• Device Lot Number: FLP23D12A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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 1158T LV LEAD; MEDTRONIC LV GUIDE CATHETER; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White