MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-062

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

Patient Problems Cardiac Perforation (2513); Device Embedded In Tissue or Plaque (3165); Pericardial Effusion (3271)

Event Date 10/13/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv) and a left ventricular (lv) lead due to non function.The patient had a baseline pericardial effusion present pre-procedure.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Multiple spectranetics devices (11f tightrail sub-c rotating dilator sheath, 13f tightrail rotating dilator sheath, glidelight laser sheath) were used to extract the ra and rv leads.The rv lead was firmly adhered within the vessel; however, the ra and rv leads were successfully removed.During attempted extraction of the lv lead, several attempts were made but were unsuccessful.The physician elected to cut the lv lead/lld near the pocket and abandoned it, with no attempt to unlock the lld from the lead.A short time after the lead extraction portion of the procedure was completed, the baseline pericardial effusion worsened and cardiac tamponade resulted.Rescue efforts began, including pericardiocentesis, and the patient stabilized without further accumulation of fluid throughout the remainder of the case.A re-implantation of new ra, rv, and lv leads was completed, and the patient was transferred to the post anesthesia care unit (pacu).Later, the patient had a cardiac arrest that resolved with continuous aspiration of pericardial fluid.Patient was returned to the operating room, and labs showed an acute and severe coagulopathy.A sternotomy was performed and three perforations were discovered: a 2 cm longitudinal perforation on the posterior aspect of the innominate vein (mdr #1721279-2022-00190), a small perforation in the right atrium (mdr #1721279-2022-00191), and a perforation to the obtuse margin, near the coronary sinus the distal tip of the lv lead was noted to be extruding from a coronary vein (near the coronary sinus, observed outside the heart wall); the lv lead was firmly adhered to the vein, just proximal to the lv lead''s distal tip.Repairs to the perforations were completed; however, the patient could not be weaned off the pump and the decision was made to implement a do not resuscitate (dnr) order and the patient expired.This report captures the lld providing traction to the lv lead, which was initially cut and capped, and later an obtuse margin perforation was discovered, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.Although the patient died, the death is captured in mdr #1721279-2022-00190.

Manufacturer Narrative

Device evaluated by mfr: a portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.Although lld cut/cap within a lead is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the ra lead prior to cutting and capping it.In addition, the subsequent cardiac perforation that was discovered 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.Reason for edit update.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15764665
• MDR Text Key: 303395075
• Report Number: 1721279-2022-00192
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2022
• 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: ABBOTT 1156T LV LEAD; ABBOTT 1888TC RA PACING LEAD; ABBOTT 7121Q RV ICD LEAD; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Other; Required Intervention; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female