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

Model Number 518-019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 01/24/2024

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and two right ventricular leads (rv models 4088 and 4137) leads due to non-function and total svc occlusion.A spectranetics lld #2 lead locking device (lld #2) was inserted into the rv 4088 lead.Multiple spectranetics devices (14f glidelight laser sheath, 11f tightrail rotating dilator sheath, 2-13f tightrail rotating dilator sheaths) were used to attempt extraction.During use of the second 13f tightrail on the rv 4088 lead and while significant traction was being applied with the lld, a small pericardial effusion was detected near the rv via transesophageal echocardiography (tee).The patient was monitored due to a suspected rv perforation.The patient's blood pressure did not change, the effusion resolved, but the rv 4088 lead was not extracted at that time.Efforts switched to remove the rv 4137 and ra leads.However, attempting removal with use of a 14f glidelight and the same 13f tightrail (traction platforms unk), the leads could not be removed from the pocket.Therefore, two abbott agilis steerable introducer-assisted wire loop snares were used to successfully extract the rv 4137 and the ra leads.Attempts were made to extract the rv 4088 lead again using the same 13f tightrail, but were unsuccessful.The tightrail was removed from the body and two agilis snares were used, one from femoral access and one from the pocket.Snaring attempts continued for at least an hour (lld remained within the lead, but traction was not being applied), with no hemodynamic changes noted, and the rv 4088 lead was eventually removed.Then, an 0.035¿ access wire was placed to prepare for re-implantation of a new lead.During re-implantation, a 7f long sheath (manufacturer unk) was inserted down the wire in the area of the superior vena cava (svc), and the patient¿s blood pressure dropped.Rescue efforts began, including cpr, sternotomy and bypass.An svc perforation (not related to any spectranetics device) was discovered and repaired, and epicardial patches were placed.No rv injury was detected post-sternotomy.The patient survived the procedure and is doing well.This report captures the lld #2 providing traction to the rv 4088 lead when an effusion was detected, requiring monitoring but resolving on its own.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

A4): patient's weight 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): suspected 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
• 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: 18761008
• MDR Text Key: 336055169
• Report Number: 3007284006-2024-00036
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 02/22/2024

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: 518-019
• Device Catalogue Number: 518-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2024
• 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: 7F LONG SHEATH MANUFACTURER/TYPE UNK; ABBOTT AGILIS WIRE LOOP SNARES; BOSTON SCIENTIFIC 4088 RV PACING LEAD; BOSTON SCIENTIFIC 4137 RV PACING LEAD; BOSTON SCIENTIFIC 438-10 RA PACING LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATHS; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TRACTION FOR RA AND RV 4137 LEAD MFR/TYPE UNK
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White