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 Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/05/2023

Event Type  Injury  

Manufacturer Narrative

A4): patient''s weight unk.D4): device lot number, expiration date unk.H3): a portion of the device was discarded, and a portion remained within the rv lead within the patient.H4): device manufacture date unk because lot number unk.H6): although lld cut/cap is a known risk of complication with the lld, the physician did not attempt to unlock the lld from the rv lead prior to cutting and capping.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 lead failure.It was noted pre-procedure that the patient had a totally occluded superior vena cava (svc).Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Using a spectranetics 14f glidelight laser sheath on the ra lead, advancement was made to the subclavian/innominate region where progress stalled.Efforts switched to the rv lead, where progress was made but stalled at the top of the svc.Moving back to the ra lead again, the glidelight (with its outer sheath) was able to progress to the svc when the patient''s blood pressure dropped, but patient was still stable.Using transoralesophageal echocardiography (toe), it was confirmed there was no blood in the pericardial space, and the physician was confident there was no blood in the chest.Continuing on the ra lead, the glidelight (with its outer sheath) was used to advance to the right atrium; however, the patient''s blood pressure dropped again and anesthesia confirmed blood in the pericardial space.Rescue efforts began immediately, including chest compressions and sternotomy.A perforation of the svc/ra junction was discovered (mdr #3007284006-2023-00001).The patient was stabilized, placed on bypass, and the repair was completed.After repair, a hematoma was identified at the back of the svc; due to this, it was elected not to extract the ra and rv leads.No attempt was made to unlock the llds from either the ra or rv leads before they were cut and capped and remained in the patient (mdr #3007284006-2023-00002 for ra lead, and mdr #3007284006-2023-00003 for rv lead).Epicardial leads were implanted at this time.However, at completion of the implant, attempt was made to take the patient off bypass, but patient became unstable and it was believed that there must be more bleeding.A ''y'' incision was made in the chest, which identified the subclavian and innominate veins had been perforated during the extraction.Attempts to repair the vessels (including vascular stenting, grafts, and plugs) failed after seven hours of effort.The patient died on the operating table.This report captures the lld within the rv lead which was cut and capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

D1): brand name corrected to lld ez lead locking device (from lead locking device) to align with brand name for the model number.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 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: 17414048
• MDR Text Key: 320034190
• Report Number: 3007284006-2023-00003
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: MEDTRONIC 5554 RA PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD; ST. JUDE MEDICAL 1488TC RV PACING LEAD
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White