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

Model Number 518-019

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

A portion of the device was discarded, and a portion remained in the patient, thus no investigation could be completed.Lld cut and cap 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 right atrial (ra) and a right ventricular (rv) lead due to superior vena cava (svc) syndrome.During prep for the procedure, it was noted the patient had significant stenosis located just above the svc/ra junction, so plans were made to balloon and stent this region during the procedure.Spectranetics lld #2 lead locking devices (lld #2s) were inserted into each lead to provide traction.In addition, attempts were made to prophylactically snare the ra lead from the groin using a st.Jude medical agilis steerable catheter introducer, an ep catheter, and a snare, to provide additional traction while attempting to extract the lead from the pocket.After approximately 30 minutes of snaring attempts, the patient's blood pressure dropped and there was a small effusion noted on transesophageal echocardiography (tee).No spectranetics devices were involved or in use during snaring attempts.The blood pressure stabilized and the effusion remained small, near the location of the ra.Beginning with a spectranetics tightrail rotating dilator sheath, the ra lead was removed.Then, efforts were focused on removing the rv lead, but little progress could be made within the subclavian region.Significant back bleeding was noted from the pocket (access site), and the patient''s blood pressure dropped again, with the bleeding ultimately controlled.Due to this, it was decided to balloon the svc prior to lead removal, since the physicians thought the bleeding may be coming from collateral vessels that had formed due to the svc stenosis.After ballooning, attempts were made to remove the rv lead using the tightrail and traction from the lld.The patient's blood pressure dropped again and the effusion was noted to be larger, but stable.Rescue efforts began, including rescue balloon and pericardiocentesis, with the tightrail and rescue balloon still in place.The pericardiocentesis was unsuccessful because the epicardial space could not be accessed.Blood pressure was monitored while the decision was made to remove the tightrail and rescue balloon, one at a time, to determine if either device was tamponading a perforation.The tightrail was removed first, and the patient''s blood pressure improved.Next, the rescue balloon was removed, and with use of blood products and medications, the patient''s blood pressure improved even more.At that point, it was decided to abandon the rv lead and proceed with a leadless pacemaker implantation.An attempt was made to unlock the lld #2 from the rv lead, but was unsuccessful; therefore, the rv lead/lld were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld #2 within the rv lead which was cut and capped and remained in the patient.

• 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: 18644413
• MDR Text Key: 334611911
• Report Number: 3007284006-2024-00027
• 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: 02/05/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC22L07A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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: EP CATHETER MANUFACTURER/TYPE UNK; MEDTRONIC 4076 RA PACING LEAD; MEDTRONIC 5068 RV PACING LEAD; SNARE MANUFACTURER/TYPE UNK; SPECTRANETICS LLD #2 IN RA LEAD; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; ST. JUDE MEDICAL AGILIS STEERABLE INTRODUCER
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White