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

Model Number 518-022

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth, age unk.Patient's weight unk.Other relevant history unk.A portion of the device was discarded, and a portion remained in the patient; thus no investigation could be completed.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 cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.While attempting to remove the ra lead with a spectranetics 16f glidelight laser sheath with its outer sheath, four attempts at advancement occurred through the patient's superior vena cava (svc) region before the patient's blood pressure dropped.Rescue efforts commenced immediately, including rescue balloon, pericardiocentesis, and sternotomy.Perforations were discovered in the svc (mdr #1721279-2023-00028) and the rv and were repaired.The physician believed that over the years, the ra lead migrated extravascular within the svc, as observed during the repair.The rv perforation occurred during the pericardiocentesis, unrelated to any spectranetics device.The ra and rv leads were not removed.The physician did not attempt to unlock either lld prior to cutting and capping the llds within the leads; both leads/llds remained within the patient (mdr #1721279-2023-00029 for ra lead/lld, this report for rv lead/lld).The patient survived the procedure, recovered, and will be re-operated in surgery at a later date for the total lead extraction.This event 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.

• 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 ; 719447-246
• MDR Report Key: 16461099
• MDR Text Key: 310442565
• Report Number: 1721279-2023-00030
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023027
• UDI-Public: (01)00813132023027(17)240629(10)FLD22F07A
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K990713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-022
• Device Catalogue Number: 518-022
• Device Lot Number: FLD22F07A
• 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: 06/07/2022
• 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: MEDTRONIC 5086 RA PACING LEAD; MEDTRONIC 5086 RV PACING LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White