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

Model Number 518-018

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/14/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and right atrial (ra) lead due to non-function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician used a spectranetics glidelight laser sheath to successfully extract the ra lead.While attempting removal of the rv lead, the physician was using a hemostat clamped on to the lld mandrel for additional traction (which is common practice and physician preference), and after pulling several times, the rv lead and lld broke at the region where the lld was clamped.The physician chose not to further attempt removal of the rv lead.The physician could not attempt to unlock the lld from the lead due to the lld breaking; the lead and lld within was cut and capped and remained in the patient.There was no reported patient harm and the patient survived the procedure.This report captures the lld present within the rv lead which broke along with the lead, and was cut and capped and remained in the patient.

Manufacturer Narrative

A portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.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: 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: 15575814
• MDR Text Key: 301501816
• Report Number: 1721279-2022-00174
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132022990
• UDI-Public: (01)00813132022990(17)231108(10)FLA21L03A
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2023
• Device Model Number: 518-018
• Device Catalogue Number: 518-018
• Device Lot Number: FLA21L03A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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: HEMOSTAT MANUFACTURER TYPE AND SIZE UNK; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White